CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH, PA, VT, and Puerto Rico
The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
No international firms.  Wholesalers in the following states:  SC, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, NE, LA, AR, TX, CO, NM,
Due to concerns of re-fermentation, bottles may burst under increased pressure.
USA: All states in USA including PR except AK, HI, WV, DE & RI.
II Glucose, For Veterinary in Vitro Diagnostic Use, 25 strips.
Arkray Factory is recalling Spotchem ll Glucose and Spotchem ll EZ Check Health Check Vet Multistrip [Panel-V] because the test strips are incorrectly reporting low blood glucose at levels above 265/dL..
II EZ Health Check Vet Multistrip [Panel-V], For Veterinary in Vitro Diagnostic Use, 25 strips.
PL4L91  PL4M92  PL5A93  PL5B94  PL5C96  PL5E98  PL5G01  PL5H02
Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA
4 GL PAIL SFF FRUIT MIX N/O - Light Syrup, UPC 4294710455
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
4 GL PAIL SFF CANTALOUPE CHUNKS, UPC 4294710419; 4/1 GL Case Cantaloupe Chunks UPC 4294740119
1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;
1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 50758108455745
1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429
1 GL JAR SFF CANTALOUPE CHUNKS - Light Syrup, UPC 4294700119
**1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810  8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904;    **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ;  **5) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904;    **6)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898  ;   **7) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898  ;  **8)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904  ; **9) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874  ; **10)  1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874   **11) 1 GL CVF FR.UIT SALAD DELUXE - LS, UPC 758108563858
1 GL PAIL and 2x1 GL/case SFF FRUIT MIX IN GRAPE JUICE, UPC 4294717155
2/1 GL SYSCO IMP. FRUIT MIX  -LS, UPC 10074865081938;
2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161
1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
2 GL, 1 GL PAIL SFF CANT/CHUNKS GRAPE JUICE, UPC 4294717119
4 GL PAIL SFF FRUIT MIX - Light Syrup, UPC 4294710455
4/1 GL SYSCO FRUIT MIX GRAPE JUICE, UPC 10074865624296
4/1 GL SYSCO IMP FRUIT MIX, UPC 10074865435236
2 GL PAIL SYSCO IMP. FRUIT MIX W/GRAPE JUICE, UPC 7486563430
4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455
1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE,  UPC 7486562450
1 GL PAIL SYSCO FRUIT MIX - LS, UPC 47486540223
3 GL PAIL SFF SEASONAL FRUIT MIX B, UPC 4294710277
1 GL PAIL SYSCO FRUIT MIX - LS, UPC 7486540223; 4 GL Pail UPC 7486572788
3rd DEGREE capsules, 60-count bottles,  Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA,	MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.
Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria.
Firm's product code N34B lot code L902095
. Product was packaged into 5 & 40 lb boxes.
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
All lots with Use by Date of 5/22/2016 to 8/31/2016
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
AL, AR, DC, DE, FL, GA, IA, IL, KY, KS, LA, MD, MI, MO, MS, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV.
Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A
2449 Cases x 6 bags of 7.6 oz each = 14,694 of 7.6 oz bags.
The condiment kits in some Caesar Salad bags contain undeclared allergens: tree nuts (walnuts).
raw frozen ground spent hen. Product is sold in 50 lbs block.
raw frozen ground spent hen is recalled due to a potential contamination with Clostridium botulinum.
Raw frozen mixed feed containing ground spent hen. Product is sold in 50 lbs. block or 1000# totes
Mixed feed containing ground spent hen are recalled due to a potential contamination with Clostridium botulinum.
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Microbial Contamination of Non-Sterile Products;  microbial contamination with B. cepacia
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;   c)  24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
576,802 cases total for product codes 7503, 7905, and 7526
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;   c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
Nationwide.  Outside the US to include:  Australia, Mexico and United Arab Emirates.
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI  53818
Non Sterility; contaminated with Klebsiella pneumoniae
US Nationwide.  The product was shipped to the following states: GA, IL, NC, NY, and TX.
Cardinal Health Shampoo Cap Fragrance Free.  1 unit per package, 30 packages per case.
The firm has recalled the product due to cladosporium (mold).
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Town and Country Compounding and Consultation Services
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Non-Sterility; microbial contamination identified as Bacillus circulans
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico  Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
ALL serial numbers and lot numbers sold since January 14, 2003.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
ALL serial numbers and lot numbers sold since 2003.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Ultroid Sterile Disposable Probes sold individually
PM Resources, Inc. dba Virbac Animal Health, Inc.
CA, FL, GA, IA, IN, MN, MO, OR, PA, TN, TX, WI and Puerto Rico
RILEXINE (cephalexin) Chewable Tablets 600 mg, 100 tablets, NDC 051311-046-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137
Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date.  The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).
RILEXINE (cephalexin) Chewable Tablets 300 mg, 100 Tablets, NDC 051311-036-10, NADA # 141326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137
RILEXINE (cephalexin) Chewable Tablets 150 mg, 100 Tablets, NDC 051311-026-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for Virbac AH, Inc. Fort Worth, TX 76137.
Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date. The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).
US nationwide.  The product was distributed to the followin states: CA, CO, FL, ID, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NM, OH, PA, SC, TN, and TX.  The product was also distributed in Puerto Rico.
OptiVet Eye Irrigating Solution with Sodium Hyaluronate, 0.1% per 14.78 mL bottle for animal use only, NDC # 51031-011-15
The products were found to contain microbial contamination.
Hy-Optic Eye Irrigating Solution, Sodium Hyaluronate packaged in 14.78 mL bottles, NDC # 51031-011-15
Optimend 0.2% Sodium Hyaluronate Gel Drops for Corneal Repair, packaged in 10 mL bottle gel drops for animal use only, NDC # 51031-013-10
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Defective delivery system: detached needles on the syringe in the kit.
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN  37217, NDC 76439-307-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN  37217, NDC 76439-308-10.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
Benton's Peanut Butter filled Cookies covered in Rich Fudge, NET WT 9.5 OZ (269 g), UPC 041 498 1896 55, Distributed by ALDI INC.    Great Value, Fudge Covered Peanut Butter, 269 g, Imported for Wal-Mart Canada Corp, Product of USA, UPC 6 28915 24342 0.
A single lot code of peanut butter used by the firm contained elevated aflatoxin levels
Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.
24CT Oatmeal Raisin Cookies  Net Wt. 24oz  UPC 208710004190
12 pack Gourmet Salted Caramel Chocolate Chunk Cookies - Net Wt.15 oz.  UPC 2897850203992 ;UPC 289785003998
12 pack Gourmet Salted Caramel Chocolate Chunk Cookies  Net Wt.15 oz.UPC 289785003998;     24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz  UPC 28977606991    8/14/2016;     12 pack Gourmet Salted Caramel Chocolate Chunk Cookies  Net Wt.15 oz.  UPC 289785020399;     24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz.  UPC 289776706990    28/29/16
Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994
Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994  08/30/16
12PK Gourmet Variety Pack Cookies  15 Oz.. UPC 289786203991    24 pack Variety Cookies Net Wt. 24 oz.  UPC 208726004191
12PK Gourmet Variety Pack Cookies  15 Oz.. UPC 289786203991 8/29/16    24 pack Variety Cookies Net Wt. 24 oz.  UPC 208726004191  8/30/16
24CT Take&Bake Oatmeal Rasin Cookies Net Wt. 24oz  UPC 20873004194
24CT Double Chocolate Cookies Net Wt. 24oz  UPC 208722004195
24CT Take&Bake Sugar Cookies Net Wt. 24oz  UPC 208906004195
24CT Candy Cookies Net Wt. 24oz  UPC 208713004197
24CT Take&Bake Party Candy Cookies Net Wt. 24oz  UPC 208902004199
Dipped Chocolate Chip Cookies  Net Wt. 24 oz UPC 269954004995
Dipped Chocolate Chip Cookies  Net Wt. 24 oz UPC 269954004995  08/30/16
24CT Chocolate Chip Cookies Net Wt. 24oz  UPC 208707004198
24CT Sugar Cookies Net Wt. 24oz  UPC  208719004191
24CT Peanut Butter Cookies Net Wt. 24oz  UPC 208716004194
Gourmet Chocolate Dipped Cookies  Net Wt. 46 oz UPC 269969414994
Gourmet Chocolate Dipped Cookies  Net Wt. 46 oz UPC 269969414994  08/30/16
24CT Take&Bake Chocolate Chip Cookies Net Wt. 24oz  UPC 208727004190
12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993     24 pack Gourmet Oatmeal Raisin Cookies  Net Wt. 30 oz.  UPC 289774706992    Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996
12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993   08/29/16    24 pack Gourmet Oatmeal Raisin Cookies  Net Wt. 30 oz.  UPC 289774706992    Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996    08/29/16
24 pack Gourmet Red Velvet Cookies  Net WT. 30 oz.    UPC 28977400000
12 pack Gourmet White Choc Chunk Macadamia Cookies Net Wt. 15 oz  UPC 289783203994    Gourmet White Chocolate  Macadamia Nut Cookies Net Wt. 30 oz.  UPC  289770006997
12 Gourmet Variety Pack Cookies - Net Wt. 15 oz  UPC 289786003997    Gourmet Variety Pack Cookies Net Wt. 30 oz   UPC 289772006995
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Non-Sterility: failed sterility test result.
Rumensin 1200GM Loose 50#;  50 pound poly woven bags.  Product code: 11005    Type B Medicated Feed. Important - must be mixed thoroughly into feed before use. This medicated feed is designed to be fed to dairy cattle.    Active ingredient: Monensin (as monensin Sodium) 1200 g/ton
Preliminary findings indicate that mixing procedures were not correctly followed leading to the possibility that lot 6222 might not be completely uniform
Worldwide Distribution - US (Nationwide)  Foreign:  Austria  Belgium  Bulgaria  Brazil  Chile  Cyprus  Denmark  Egypt  Finland  France  France  Germany  Greece  Hungary  Iran  Ireland  Israel  Italy  Japan  Kenya  Kuwait  Latvia  Luxembourg  Mexico  Namibia  Netherlands  Nigeria  Norway  Poland  Portugal  Romania  Saudi Arabia  Serbia  Slovakia  South Africa  Spain  Sweden  Switzerland  Turkey  United Arab Emirates  United Kingdom
Covidien Clearify Visualization System  Item  Code: 21-345  Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Product sterility is compromised due to breach of the sterile barrier
Lots beginning with:  P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M,  P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX
Best Practices kits containing certain production lots of Clearify Visualization System  Item  Code: 21-345  Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Brownwood Farms Yankee Bourbon BBQ Sauce.  19oz glass bottles and 1 gallon
Products contain soy  ingredients not declared on the label.
All product on market, any best by date prior to 9/21/2018.
Brownwood Farms Peach Salsa.  17oz glass bottles.  Private labels:  Bowers Harbor Vineyard (Peach Salsa 12oz).  Crossroads.
Products contain yellow#5 ingredients not declared on the label.
All product on market, any best by date prior to 9/30/2017
Brownwood Farms Apple Riesling Salsa.  21oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Apple Riesling Salsa 21oz).  Kimmel Orchard & Vineyard (Apple Riesling Salsa 21oz).  St. Julian Winery (Apple Riesling Salsa 19oz).
Brownwood Farms Cherry BBQ Sauce.  21oz glass bottles, 1 gallon, 5 gallon.  Private labels:  Arbor Day Farm (Cherry BBQ Sauce).  Bowers Harbor Vineyard (Cherry BBQ Sauce 12oz).  Benjamin Twiggs (Northwoods Cherry BBQ Sauce 16oz).   Crossroads.  Friske Orchards.  Kimmel Orchard & Vineyard (Cherry BBQ Sauce 21oz).   Six Lugs.  Spirit Valley.  Westborn's cherished (Cherry barbecue sauce 21oz).
Products contain soy ingredients not declared on the label.
Brownwood Farms Jalapeno Cherry Salsa.  21oz glass bottles and 1 gallon.  Private labels:  Arbor Day Farm (Cherry Jalapeno Salsa 21oz).  Kimmel Orchard & Vineyard.
Brownwood Farms Jalapeno Cherry Butter.  12oz glass bottles and 1 gallon.
All product on market, any best by date prior to 9/30/2018
Brownwood Farms BBQ Mustard Glaze.  11oz glass bottles and 1 gallon.  Private labels:  Kimmel Orchard & Vineyard (Barbeque Mustard 11oz)
All product on market, any best by date prior to 9/21/2018
US nationwide.  The products were shipped to three government facilities. The products were distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA SC, TN, TX, UT, VA, VT, and WI.
CESAR Classics Filet Mignon Flavor, 100 g (3.5 oz) in plastic trays, 24 or 30 trays/case
There is a potential presence of white plastic in the finished product.
Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use.  AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2)  5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG,  Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG,  Item Number H787065970555, Catalog No.REF 06597055  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069  Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Darwin's Natural Selections brand, frozen, raw Turkey  with Organic Vegetable Meals for Dogs, 2 lbs. packages
Several meals for dogs are recalled due to contamination with Listeria monocytogenes
Lot # 3142070, manufacturing date: 7/20/16.
ZooLogics brand, frozen, raw Turkey with Vegetable Meals for Dogs, 2 lbs. packages.
Lot # 3155070; manufacturing date 7/25/16.
Darwin's Natural Selections brand, frozen, raw Beef with Organic Vegetables Meals for Dogs, 2 lbs. packages
Lot # 3146070, manufacturing date: 7/21/16.
US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS,AR, CO, NE, NY, VA, AZ, OK).    OUS: Germany
Nuvectra is conducting a recall due to two clinical risks that are  associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System.  It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Medtronic SynchroMed II Implantable Drug Infusion System.  This system includes:  Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer,  and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.)     Product  Usage:  The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System.  Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
software application cards with versions other than AAU01
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Worldwide distribution.  U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
LMA MADomizer, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
LMA MADdy, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE SHORT    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE LONG, 10 Boxes of 25 units each    Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADgic, Atomization Device with 3mL Syringe, Rx only,     Product Usage:  These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical.  For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
IA, MD, NY, WA  Foreign: France, Germany, The Netherlands, Hungary, Singapore
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960)  Item Number: 6000677.  Used with the: JANUS AUTOMATED WORKSTATION   Product Codes:  AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01  NGS EXPRESS Product Codes: AJS4NGS
Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
Select Whole Foods Market stores in Pennsylvania, Maryland, Ohio, Kentucky, New Jersey, Virginia and Washington D.C.
Total volume made and distributed from 8/1/2016-11/2/2016: Chocolate Croissant 6pk: 7892 units.
UPC Code   Product Desc   Lot Code      0248422008994  CROISSANT CHOCOLATE 6 PK  sell by 11/5 and before
Total volume made and distributed from 8/1/2016-11/2/2016: Plain Croissant 6pk: 42118 units.
UPC Code   Product Desc   Lot Code      0248421006991  CROISSANT 6 PK.  sell by 11/4/16 and before
Total volume made and distributed from 8/1/2016-11/2/2016: Multigrain Croissant 6pk: 1547 units.
UPC Code   Product Desc   Lot Code      0241654006998  MULTIGRAIN CROISSANT 6PK  sell by 11/4/16 and before
Distributed in the state of Pennslyvania.
Raisin Bagel with Cream Cheese wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil), and Milk
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
Sausage, Egg and Cheese on Kaiser wrapped in clear film, 5 oz.  Undeclared allergens - Wheat, Soy(oil, lecithin) Milk
Chicken Salad on Kaiser Roll, 5 oz.  Undeclared allergens - Wheat, Soy (oil, flour)
Regular Hoagie on Italian Roll, wrapped in clear film, 7 oz.   Undeclared allergens - Wheat, Soy (oil), Milk
Cheeseburger wrapped in clear film, 5 oz.   Undeclared Allergens - Wheat, Soy (Lecithin, oil, flour), Milk,
Hot Sausage on Club wrapped in clear film, 6 oz.  Undeclared allergens - Wheat, Soy (oil)
Turkey Club on White wrapped in clear film, 4 oz.   Undeclared allergens - Wheat, Soy (oil)
Imported Ham with Potato salad wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil), Milk, Egg
Bagel and Cream Cheese wrapped in clear film, 5. oz.
Roast Beef and Cheddar Cheese on Kaiser Roll wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk
Mild Italian Sausage on Italian Roll wrapped in clear film, 6 oz.   Undeclared allergens - Wheat, Soy (oil, flour)
Meatball on an Italian Roll with Cole Slaw wrapped in clear film, 8 oz.    Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
Ham and Cheese on Club wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil, lecithin), Milk
Hot Sicilian- Ham, Pepperoni and Provolone Cheese wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy( oil flour), Milk
1/4 1b. Hot Dog with Cheese wrapped in clear film, 6 oz.   Undeclared allergens - Wheat, Soy(oil, lecithin) Milk
Salisbury Steak with Gravy on Kaiser with whipped potatoes wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk
Bacon Egg and Cheese on Kaiser Roll wrapped in clear film, 5 oz.   Undeclared allergen - Wheat, Soy (oil, lecithin), Milk, Egg
Turkey, Bacon and Swiss on Macaroni Salad wrapped in clear film, 8 oz.   Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
Vegetable and dip, 6 oz.   Undeclared allergens - Soy( oil), Milk
Egg Salad on Wheat wrapped in clear film, 5 oz.   Undeclared allergens - Wheat, Soy (oil) and eggs
MTR MASALA Sambar Powder, Net Quantity: 200g
The firm distributed a product prior to FDA release for an article which appears to contain Salmonella and was Subject to Import Alert #99-19
Duloxetine Delayed-release Capsules USP 30 mg  30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Medi Choice Arm Slings    ASL 2103	Small 7.5 x 12.5 Inch	1/EA, 24 ENCA  ASL 2104	Medium 8 x 15 Inch	1/EA, 24 ENCA  ASL 2105	Large 8.5 x 17.5 Inch	1/EA, 24 ENCA  ASL 2106	Extra-Large 9 x 20 Inch	1/EA, 24 ENCA  ASL 2150	Universal 7 x 18 Inch	1/EA, 24 ENCA    Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
1, 2016 reported surface contamination on the arm slings.  Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue.    Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions.  A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016.  The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots.    Owens & Minor has quarantined the affected product lots.  The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time.    Based  on the frequency  of the product  defect as well as evaluation of potential  adverse health event risk, Owens & Minor initiated  a voluntary  recall for the above stated affected  product  lots.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
American Red Cross Blood Services Tennessee Valley Region
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of :  Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Affected Generations (GENs): 3, 11, 12, 30 through 36
Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries
NORTHERN CLASSICS NATURAL SMOKED STEELHEAD***  Product  is packaged in bulk 5lb case.  Product  is vacuum packaged catch weight.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.
***PREMIUM SMOKED SALMON***CRACKED PEPPER*** NET WT: 4OZ***Packaged 5 lbs case 20/4oz vacuum packages/case. Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.  UPC 7 02772 00560 2.
WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ***  UPC 7 02772 00559 6.  Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.
***NORTHERN CLASSICS NATURAL SMOKED SALMON. Net WT. is filled in on a separate white label. Product is frozen and vacuum packed.  Product also referred to as SALMON HOT SMKD SIDE ATL SK-ON.
PREMIUM SMOKED SALMON***CAJUN***NET WT:  4OZ***Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.  UPC 7 02772 00562 6.
PREMIUM SMOKED SALMON  UPC 7 02772 00564 0    Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded over and affixed to the top of the package.  Sell by date is marked on the label by the consignee.
***NORTHERN CLASSICS FINEST QUALITY KIPPERED SALMON CHUNKLETS. This package can be combined with other products and placed into a combination package. Each package is individually labeled.  Bulk cases contain 5 lbs.
CA, CO, NY, WA  Foreign:  Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands,  Japan, Great Britain,
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Worldwide Distribution - US including FL and MA.  Internationally to Canada
Insufflator, laparoscopic    The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Blood products, mislabeled as to antigen phenotype, were distributed.
Blood Product, collected from a donor who disclosed receiving a vaccine within eight weeks of donating, was distributed.
US Distribution to the states of : PA, FL, NJ, IL and MA.
Gammex  Non-Latex Sensitive  Neoprene Surgical Gloves  Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka    Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium    Manufactured for/ Fabrique' pour:  Ansell Healthcare products LLC.  1635 Industrial Road Dothan, AL 36303, USA  TEL USA- 1-800-952-9916 CAN- 1-844-494-7854    catalog  #20277285
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Ariels OM Grown Granola.    Product number GR200, net wt. 5 lb., packaged in bulk bag inside plastic bucket.  Product number GR201, net wt.15 lb., packaged in bulk bag inside plastic bucket.  Product number BAG-GR200, net wt. 8 oz., packaged in cellophane bag with cardstock label.  Product number SBAG-GR200, net wt. 4 oz., packaged in cellophane bag with cardstock label.
Ariels Om Grown Granola is recalled because it was contaminated with wheat seed.
5lb and 15lb bulk containers have a manufacturing date (mm/dd/yy) stamped on label or bucket: 070315 through 100616, or a Julian date of 16294 through 16331.    4 oz and 8 oz packages have a Julian code of 15184 through 16331.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of :  Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Foreign Distribution in the  Italy, France, Switzerland, Germany, Sweden
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
Covidien issued a labeling update for the Covidien Devon Light Gloves.  Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Lot Number 1230323, Exp. Date December 2016;   Lot Number 1230387, Exp. Date December 2016;   Lot Number 1231616, Exp. Date December 2016
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Lot Number 1530330, Exp. Date November 2017;   Lot Number 1530241, Exp. Date September 2017;   Lot Number 1530095, Exp. Date September 2017;   Lot Number 1431734, Exp. Date August 2017;   Lot Number 1431066, Exp. Date May 2017
CARPAL TUNNEL PACK, Surgical Instrument Tray,  REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Lot Number 1230783, Exp. Date February 2017;   Lot Number 1330825, Exp. Date April 2018
Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
OrthoPediatrics PediNail Intramedullary Nailing System  4.5mm X 48mm Cortical Screw
Labeled as a 48mm Cortical Screw but measuring at 50mm
Product Number: 10-1500-3048  Lot Number: 161421-G
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
A limited number of product pouches may not have been sealed during packaging.
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER    An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H)  An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Nationwide in US &     Worldwide:    CA, AU, GB, ES, FR, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, DO, FI, GI, GR, HR, HU, IE, IL, IT, JP, LT, LV, MT, MX, MY, NG, NL, NO, NZ, PH, PL, RE, RO, RU, SE, SG, SI, SK, TH, TR
Naturecom dba NutriVitaShop is recalling DMAA net weight 500 g because there may be presence of 1,3-dimethylamylamine.
BuPROPion Hydrochloride Extended-Release Tablets (XL),  300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and  b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Failed Dissolution Specifications; 6 month time point
Northern California Community Blood Bank
Platelet products, which failed leukoreduction quality control, were distributed.
OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA,  MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile,    Intermittent self-catheterization
Labeling Inconsistency: The products have been  labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico.  Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Complaint  that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM  D66CM  Catalog # AB10218  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM  D84CM  Catalog # AB081211  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM  D66CM  Catalog # AB081210  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM  D84CM  Catalog # AB101219  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM  D66CM  Catalog # AB101218  Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Labeling: Label Mix Up- Incorrect back label applied to the product.
Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R    Intended for the temporary stabilization of bone segments or fragments
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia,   Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.
Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland,  India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico,  Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines,  Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK    For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
4705 kits (US: 390 kits; OUS: 4315 kits)
Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
All lots  LKPS1/LKPS5 - Lots 443, 445, 446  LKPTS1 - Lot D116
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK    For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
6697 kits (US: 1646 kits; OUS: 5081 kits)
Siemens Healthcare Diagnostics confirmed that the  IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
All lots  L2KPS2/L2KPS6 - Lots 408, 409, 410  L2KPTS2/L2KPTS6 - Lots D112, D123, D124
Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet
Coliman Pacific Corp is recalling Jalapeno Peppers because they may be contaminated with Salmonella.
The product is an acidified food without a registered manufacturer and scheduled process
Rissois De Camarao Cong. Frozen Shrimp Cakes, Frozen 50 count. Net Weight: 4,50Kg (2 x 2,25Kg)  Country of Origin: PORTUGAL
Failure to declare ingredients in English: allergens (soy, sulfite, yellow #5, and MSG ) and unpermitted food color E124 - Ponceau 4R
Batch: 031.016  Best before: 22 Mar 2018
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Microbore extension set with slide clamp; Product Code: AMS-651    Product Usage:  Accessory devices used to administer medical fluids.
Incorrect priming volume is printed on the device package.
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Synthes VA Implant Rack for the Compact Distal Radius System  Tray/Surgical/Instrument
The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Catalog ID (part # 60.119.012), Lot Number FL00528
United States, United Arab Emirates, and Colombia
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Product distributed in NC and nationwide through the internet.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY  10007.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
AQURE System   Software Version 2.2.0  Model #: 933-599  UDI: (01)05700699335999(10)2.2.0   Catalog number: 933-599  The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Philips Electronics North  America Corporation
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Ingenia MR-OR; 781437, 781438  The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Possibility that a patient or user may be exposed to a very small level of touch current.
Preferred Meals, Cook and Serve, Creamy Red Pepper Sauce and Cheese Tortellini with Parmesan Cheese, 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
Possible contamination of product with Listeria monocytogenes.
Preferred Meals, Cook and Serve, Cavatappi Pasta with Mascarpone Tomato Cream Sauce; 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
US Distribution to the states of : GA. MI, OK, SC, TX, VA
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match.  The primary label matched the label on the inner pouch, but the patient label was incorrect.
Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
US Distribution to the states of : FL, GA. IL, MO, TX
Complaints that the tip of the awl broke after impaction during surgery.
Part Number 139005 - Lot Number 182-16146
Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200     The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
The rods are packaged in packages with unacceptable seals.  In some cases, the integrity of the seal is compromised by channels or voids.
Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U  The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Dual Stylet Needle, Part Number 812-11R-15  The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
EnLite instrument.  The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Unique Device Identifier (UDI) is missing from outer kit box label.
Streit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel
The Commonwealth of Virginia sampled the product and revealed the presence of undeclared sulfites at 57 ppm and 10 ppm
Platelet product, for which quality control testing did not meet specifications, was distributed.
Lifesouth Community Blood Centers - Montgomery Region
Platelet component, for which product QC was unacceptable, was distributed.
Nationwide Distribution to IN, LA, and TX
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123   The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030  The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Phil-am Trading, Inc.  is recalling Phil-am Smoked Mackerel (Hasa-Hasa), because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
distribution dates -February and November 2016;    no codes on product
American National Red Cross (The), Lewis and Clark Region
Blood products, for which donor screening was performed incorrectly, were distributed.
Malayuguo, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
The product is a low acid canned food (LACF) without a registered manufacturer and scheduled process.
Heihujiaoyupai, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
Qiejidingxiangyu, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of:  China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan.    480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions.     15 US government sites received affected product
collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
SurePath Collection Vial Replacement Cap, cat no. 490505  SurePath GYN Preservative Vial Kit, cat no. 490527  SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095  SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096  SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097
Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC.  Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.    Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when  radiation treatment is indicated.
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
DF Coated Integral Shaft & Stem    15x30x38; DF Coated Integral Shaft & Stem    15x36x44; DF Coated Integral Shaft & Stem    30x30x38; DF Coated Integral Shaft & Stem    30x36x44    The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Femoral Integral Shaft & Stem  15x27  HA Coated; Femoral Integral Shaft & Stem  15x30  HA Coated; Femoral Integral Shaft & Stem  30x27  HA Coated; Femoral Integral Shaft & Stem  30x30  HA Coated  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm  The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Fairway  Group Holding Corp dba  Fairway Bakery LLC
New York, New Jersey and Connecticut and via the internet
FAIRWAY LIKE NO OTHER MARKET brand CANDY CORN, of varying weight, Item Code 228402 XXXXXX -- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. --- PACKAGED BY FAIRWAY MARKET 2284 12TH AVE., NEW YORK, NY 10027
Nationwide, China, Germany, Norway, UK, Canada, Ireland, Italy, Australia, New Zealand, Hong Kong,  Croatia
CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460
Product was analyzed and found to contain 1,3- dimethylbutylamine which was not declared on the label and is a prohibited substance.
Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI.  Foreign distribution was made to Canada, as well as other countries.
Merge OrthoCase software.  The firm name on the label is Merge  Healthcare, Hartland, WI.
30 sites potentially have the effected versions
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Nationwide  Foreign:  Dubai, Egypt, Guam
Haemonetics El Dorado Donor  Blood Establishment Computer Software (BECS)
Blood bank software, with a defect or glitch, was distributed.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Distributed in Idaho, Maryland, Nevada, Oregon, and Washington
White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz.
White Fudge Oreo is recalled due to undeclared wheat and blue # 1.
Plain Fudge, brand Real Fudge.  Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
290/8 oz. units; 60/12 oz. units; 18/16 oz. units; and 5/24 oz. units
Plain Fudge is recalled due to undeclared blue #1.
Nutty fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
261/8 oz. units; 60/12 oz. units; 16/16 oz. units; and 11/24 oz. units
Nutty fudge is recalled due to undeclared blue #1.
Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Coconut Fudge is recalled due to undeclared blue #1.
Dark Chocolate Fudge, brand Real Fudge.    Product is sold in clear plastic deli container in 8, 16, and 24 oz.
82/8 oz. units;  5/16 oz. units; and 2/24 oz.
Dark Chocolate Fudge is recalled due to undeclared blue #1.
Salted Caramel Fudge, brand Real Fudge.  Product is sold in clear plastic deli container in 8, 16, and 24 oz.
73/8 oz. units; 4/16 oz. units;  3/24 oz. units
Salted Caramel Fudge is recalled due to undeclared blue #1.
White Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
White Fudge is recalled due to undeclared blue #1.
Peanut Butter Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
78/8 oz. units; 60/12 oz. units; and 7/16 oz. units
Peanut Butter Fudge is recalled due to undeclared blue #1.
Rocky Road Fudge, brand Real Fudge.   Product is sold in clear plastic deli container in 8, 12, and 16 oz.
59/8 oz. units; 60/12 oz. units; and 7/16 oz. units
Rocky Road Fudge is recalled due to undeclared blue #1.
Blood products, not tested according to specifications, were distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.
American National Red Cross, Penn Jersey Region
Blood product, in which donor suitability was not adequately determined, was distributed.
United States and Puerto Rico  No foreign distribution.
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial,  Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Lack of Assurance of Sterility: Potential cracks in glass vials
Phenylephrine  2.5% + Tropicamide 1%  Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99    Sterile compounded drug, Hospital/office use only, Not for resale  Storage: ROOM TEMP