Stryker Medical Division of Stryker Corporation
US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK.
Customer complaints associated with faulty brake system
MN, ND, WI. NJ, TN FL, OH, MI, CA, TX, LA, NC, SC, NE, NY, PA, IL.
Red Blood Cells, Leukocytes Reduced Irradiated
Blood products, lacking assurance of sterility, were distributed.
Distributed nationwide to AL, AZ, CA, FL, KY, MI, OH, OR, PA, TX, WA
Concentrated coffee packed in 1/2 gallon or 1 gallon hermetically sealed Scholle or Liquibag.
The pH level in coffee product was elevated above 4.6.
Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
Autologous serum mixed with sodium chloride solution for ophthalmic application.
Autologous Drops (serum tears), that may be associated with lack of stability and sterility assurance, were distributed.
Suan's Scotch Bonnet Pepper Relish 9.8 oz. packaged in a glass jar with a metal lid.
Some jars were reported to have swollen or leaking lids.
Family Dollar Stores - NC Distribution Center
Nationwide - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, SD, TX, UT, VT, VA, WV, WI, WY
Family Gourmet Long Grain Enriched White Rice, 32 oz. (2 lb.) plastic bag (SKU: 1218898)
Live insects were noted inside several unopened bags of product.
Lot # 061HO415; Best By Date: March 02, 2017  Lot # 054HO215; Best By Date : February 23, 2017
Family Gourmet Natural Whole Grain Brown Rice, 32 oz. (2 lb.) plastic bag (SKU: 1230394)
Lot # 3047GP15; Best By Date: February 16, 2016  Lot # 3076GP15; Best By Date: March 17, 2016
Fresh Express, Family Size Baby Spinach, Net Wt. 12oz in clear flexible plastic bags.
350 Cases x 8 bags of 12oz each = 2800 12 oz bags.
Use By Jan 24, Product Code: G010A17A, Product of USA
3m Center 2510 Conway Ave , B# 275-5-W-6
AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include:  Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.
3M Steri-Vac Gas Sterilizer/Aerator,  models 5XL and 8XL.
orientation.  This defect can result in the valve being installed backwards, creating a remote possibility of valve failure.  A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
Distributed in the states of AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN, and TX, and the countries of Canada and UK.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - US Nationwide in the states of CA, FL, ID, TX, OK, OH, MA, and NC and the countries of Australia Belgium, Egypt, Germany, Ghana, Italy,  Japan, Poland, South Africa and UK.
Trinity Acetabular Shell     Product Usage: Total Hip Replacement.
Potential for abrasion of the sterile barrier pouches of the new packaging system.
Cluster Shell 044mm Taper Size 1,  Lot Code:  320023; Cluster Shell 046mm Pager Size 2, Lot Code: 320018; Cluster Shell 048mm Taper Size 2, Lot Codes: 321691, 322402, 322981, 322982, 323745, 323746, 324298;  Cluster Shell 050mm Taper Size 2, Lot Codes:  321954, 322753, 322980;  Cluster Shell 050mm Taper Size 3, Lot Codes:
Trinity Acetabular Shell    Product Usage Total Hip Replacement.
Trinity Acetabular System    Product Usage - Total Hip Replacement.
Non Occluded TPS Shell 048mm Taper SZ2, Lot Code:  323741
Canada, Sweden, France, China, and United States.
Mentality Nail Polish 0.5 oz/15 ml, all colors    All nail polish produced in the following packaging-  Round bottle, black cap, white screen printed logo  Round bottle, black cap, black screen printed logo  Round bottle, black cap, white or clear vinyl label with either 5 Free, Matte, Gloss, Glaze, Texture, or Opaque on the lower left portion of the label.   Round bottles with 3 Free printed on the label ARE NOT included in this recall.
Mentality Cosmetics is recalling Mentality Nail Polish that were sold from 4/22/15 through 6/19/15 due to problematic batches that were manufactured with Arminex International nail polish bases.
no codes.    Lot numbers were not assigned by us per bottle. These bottles were small batch-colored, hand-mixed, hand poured items. Official recall includes product sold April 2015 to June 2015.
Organic traditions SPROUTED FLAX SEED POWDER, NET WT. 8 oz/227g, UPC 854260006261 --- The product is packed in a sealed flexible plastic bag.
The repacked product has the potential to be contaminated with Salmonella.
Lots: AHM626151103 Exp. 09/2017, AHM626151229 Exp.10/2017 (lot located near UPC barcode on back of bag)
Organic traditions SPROUTED CHIA & FLAX SEED POWDER, NET WT. 8 oz./227g (UPC barcode 854260006216), and NET WT. 16oz./454g bag (UPC barcode 85426000547) --- The product is packed in a sealed flexible plastic bag.
Shipped to nineteen retail accounts nationwide (Colorado, New Jersey, New Mexico, New York, Oregon, Utah, and Washington) and two direct consumer accounts (Missouri and New York). There was no military/government/foreign distribution.
Bissinger's Milk Chocolate Eggs packaged in 6.5 oz (UPC 846107009382) Item: #11108 or 1 lb. (UPC 846107003458) Item: # 111049 plastic bags.  Bissinger's Handcrafted Chocolatier, St. Louis, MO.
22-12 ct. case of 6.5 oz. bags of foil wrapped milk chocolate eggs and 2-1 lb. bags of foil wrapped milk chocolate eggs
The chocolate used in the product contains vanillin (an artificial ingredient) but is labeled to contain vanilla.
USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
ABX Pentra 400 (version 5.0.8 or lower)    The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
Pentra C400 (version 1.1.2 or lower)    The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Product was distributed to CA, CO, GA, IA, IN, MN, MO, NC, NE, OR, SC, TX, UT, VA, and WI.  There was no military/government/foreign distribution.
Macadamia Diced Nuts packaged under the following brands:    1) Shurfine, Item no. 86635, 5 OZ (142 g) plastic bags, packed 12 bags per case, UPC 0 15400 86635 4.  Distributed by Western Family Foods, Inc., Portland OR.     2) Western Family, 5 OZ (142 g) plastic bags, packed 12 per case, UPC 0 15400 16635 5.  Distributed by Western Family Foods, Inc., Portland, OR.     3)  HyVee, 2 OZ (57 g) plastic bags, packed 12 per case, UPC 0 75450 13287 8.  Distributed by HyVee, Inc., West Des Moines, IA.     4) Market Pantry, 2.25 OZ (64 g) plastic bags, packed 12 bags per case, UPC 0 85239 52108 3.  Distributed by Target Corp., Minneapolis, MN.    5) Pear's Gourmet, 16 OZ (454 g) plastic bags, UPC 0 75049 42186 4.  Pear's Gourmet, Bellevue, NE 68005.    6) CWD, 5 LBS. (2.27 kg) per 1-count case, UPC 06509.  Packed for and distributed by Cash-Wa Distributing Co. Kearney, North Platte, Sidney, NE.    and  7) Nutpro C.C. Macadamia Nuts Style #5, 25 LBS., bulk case item no. N0609.  The responsible firm is Nutpro South Africa.
Product potentially contaminated with Salmonella. Routine, random product sampling by FDA revealed the presence of Salmonella in a retail package of macadamia nuts packaged by the recalling firm.
Product 1 - Shurfine) Best By: 2 SEP 2016;  Product 2 - Western Family) Best By:  3 AUG 2016, 4 AUG 2016, 2 SEP 2016  Product 3 - HyVee) Best By:  10 JUL 2016  Product 4 - Market Pantry) Best By:  13 AUG 2016, 11 SEP 2016  Product 5 - Pear's Gourmet) Best By:  11 SEP 2016, 25 SEP 2016  Product 6 - CWD) lots 15204 andn 15260  Product 7 - Nutpro, bulk) lot 79818
US Consignee: NY ***Foreign Consignee: Ecuador
Automated peritoneal dialysis (APD) cycler
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations.     The tot
Nature's Eats Almond & Pistachio Duo NET WT 6 OZ (170g) packaged in clear cello bag
Potential to be contaminated with Salmonella.
Nature's Eats Austin's Nutty All-Terrain NET WT 12 OZ (340g) packaged in clear cello bag
Fresh Choices Survivor Mix NET WT 4.75 OZ (135g) packaged in clear cello bag and Nature's Eats Survivor Mix NET WT 10 OZ (284g) packaged in clear cello bag and Southern Grove Survival Trail Mix NET WT 10 OZ (283g) packaged in clear cello bag
Nature's Eats Hill Country Ramblin' NET WT 15 OZ (425g) packaged in clear cello bag
Nature's Eats Simply Go Raw NET WT 8 OZ (227g) packaged in clear cello bag
Nature's Eats Natural Pistachios NET WT 8 OZ (227g) packaged in clear cello bag and Bulk RAW PISTACHIO - 25 LBS and Bulk RAW PISTACHIO - 5 LBS packaged in corrugated box
Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.
RESTORIS PST RIO Offset Shell Impactor    For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Potential disassociation of the orientation pin.
Leukoreduced Plateletpheresis products, that failed residual WBC counts, were distributed.
W203416843518 (triple collection); W203416843522 (double collection)
Blood products, collected from an ineligible donor, were distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, collected from a donor who possibly traveled to a malarial endemic area, was distributed.
Blood Systems, Inc.  dba UBS - California
Blood products, possibly 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.
Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 41120 7
A natural flavoring containing a milk ingredient was inadvertently used to manufacture the Duncan Hines Signature Swiss Chocolate Cake Mix, 16.5 oz. cartons and the Duncan Hines Swiss Moist Deluxe Swiss Chocolate (Chocolate Suizo) 16.5 oz. cartons. The incorrect labeling was used on this product declaring that these products were a NON-milk containing product.
Case Lot #6521017E31 with Best By: Jan 21 2017
Duncan Hines Moist Deluxe Swiss Chocolate (Chocolate Suizo) Cake Mix, Net Wt. 16.5 oz. (1 LB 5 oz.) 468 g, Distributed by: Pinnacle Foods, Cherry Hill, New Jersey USA, UPC 6 44209 309748 7
Worldwide Distribution - US Nationwide in the states of: MA, NY and countries of : Algeria,  Australia,  Austria,  Bahrain,  Belgium,  British Virgin Islands,  Bulgaria,  Canada,  Denmark,  Egypt,  Estonia,  Finland,  France,  Georgia,  Germany,  Greece,  Hong Kong,  India,  Iran,  Iraq,  Ireland,  Israel,  Italy,  Japan,  Jordan,  Korea,  Kuwait,  Libya,  Lithuania,  Macedonia,  Malaysia,  Malta,  Mexico,  Nigeria,  Norway,  Pakistan,  Peru,  Poland,  Romania,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sri Lanka,  Sweden,  Taiwan,  Thailand,  Tunisia,  Turkey,  UAE,  Ukraine,  United Kingdom,  and Vietnam,
Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160    Product Usage:  The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing.
The units have been fitted with a potentially faulty power supply cable.
Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India,  Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code  6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File.  The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.  The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate.  The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage.  The Recapper Module is supplied by Thermo Fisher Scientific.
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate.  If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
GE Healthcare, Aisys and Aisys CS2.    Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.
U.S. distribution via online sales to the following; CA, TX, MI, PA, NY, MD, FL, GA, MS, MO, NC, IL, OH, CT, WY, MN, KS, IN, VA, OR, NJ, AL, AZ, MA, RI, CO, TN, KY, UT, DE, WA, NH, OK           No foreign distribution.
The Super Elixir  By WelleCo  Australia    Alkalising Greens  150g/5.3 oz net, 300g/10.6 oz net  Fine Powder    welleco.com
Welle Pty Ltd is recalling Wellco Super Elixir pouches because of potential Salmonella contamination
DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use  Part Number D 12442  C384
Worldwide Distribution -  US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX.  and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.
Drew Scientific Inc. Drew3-PAC.  This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a  lysing reagent 125 mL.
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Nationwide Distribution to AL, CA,  MA, and TX.
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm  Material Number: M00576550     The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths
Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Lot Number: 18876596 Exp Date: February 1, 201 8
US Distribution -- to the stated of FL, MA, MI, MS, PA, and KS.
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure).    For medical use by professional medical staff.
The adherence check generates a software error.  Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the date 14 days later.   An error message is generated and forwarded to operations.   Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement.    If the pa
Worldwide distribution.  US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan,  Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.
PneumoSure XL High Flow Insufflator and  PneumoSure High Flow Insufflator;  High pressure units  (HPU) (40L and 45L).    Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684    The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
HPUs affected lot numbers 0005051337-000505052795;  PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical.    Product Usage:  Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
The label on the Tyvek bag is missing.  This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.
Nationwide Distribution to OH, TX. FL, CA and GA.
Magellan Robotic Catheter Accessory Kits,  Model number MACC 50 and MACC80.    Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Hand-Held Scanner USB IT3800  For sample identification and tracking when used with various systems
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
MA, ME, NH, NY, NJ, CT, RI  Foreign: Thailand, China
Bliss Toffee Crunch Ice Cream 64oz  Product Code:51065
Product failed to meet air space specifications
Emack & Bolios  Moose  Ice Cream 3gal  Product Code: 36257
Bliss Mix 5% Yog 5gal FRESH  Product Code: 79801
Newport Creamery Butter Crunch Ice Cream,  3Gal  Product Code:  35108
Cresent Ridge Coffee Ice Cream 3 gallon   Product Code:    36102
Cresent Ridge Oreo Cookie Ice Cream  48oz  Product Code: 35424
Cresent Ridge Choc Chip Cookie Dough 48oz  Product Code:  35418
Emack & Bolios Grasshopper Ice Cream 3gal  Product Code:  36272
Newport Creamery Coffee Ice Cream,  3Gal  Product Code:  35104
Emack & Bolios Mud Pie Ice Cream, 3gal  Product Code: 36269
Cresent Ridge Vanilla Ice Cream  48oz  Product Code:   35410
Emack & Bolios Pistachio Ice Cream, 3gal  Product Code:  36262
Emack & Bolios Oreo  Ice Cream ,3gal  Product Code:  36265
Emack & Bolios Space Cake Ice Cream, 3gal  Product Code:  36273
Cresent Ridge ChocChp CookiDgh WRAP Ice Cream 48oz  Product Code:  35403
Emack & Bolios Caramel Moose Prints Ice Cream, 3gal  Product Code: 36285
Bliss Moose Tracks Ice Cream 64oz    Product Code: 51049
Emack & Bolios Stoney's Dream Ice Cream, 3gal  Product Code:  36276
Emack & Bolios Cake Batter Ice Cream, 3gal  Product Code: 36266
Bliss French Vanilla Ice Cream 64oz  Product Code: 51051
Emack & Bolios Serious Choc Addiction Ice Cream 3gal  Product Code: 36271
Cresent Ridge Vanilla  Ice Cream 3gal  Product Code:  36100
U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
Hardy Diagnostics GBS Detect  Cat no. A300.    Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
Mindray DS USA, Inc. dba Mindray North America
Panorama Patient Monitoring Network  Mindray DS USA   The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.
Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.
Panorama Central Station's CPU Unit, Tower (p/n 0998-00-0709-01)  Panorama Central Station's CPU Unit, 2U case (p/n 0998-00-0708-01)  Panorama Centrall Station's eGateway Tower (p/n 0998-00-0709-03)  Panorama Central Station's eGateway 2U case (p/n 0998-00-0708-03)
Distributed to 499 consignees in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, 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, VA, VT, WA, WI, WV, WY and PR. The one foreign consignee is Natulab in Japan.
Elderberry 500 mg packaged in a white and orange bottle containing 60 capsules. The bottle has a blue cap and white lettering.
Undeclared soy lecithin in 5 dietary supplements.
Goldenseal Root 500 mg  packaged in a white and orange bottle containing 100 capsules. The bottle has a blue cap and white lettering.
Andrographis extract 400 mg packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
Gingko Biloba 60mg  packaged in a white and orange bottle containing 120 capsules. The bottle has a blue cap and white lettering.
Cranberry extract packaged in a white and orange bottle containing 90 capsules. The bottle has a blue cap and white lettering.
US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX.    OUS: SINGAPORE
OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Roland (R) Fire Roasted Red Pepper Strips, NET WT. 5 LB. 8 OZ. (2.5 kg), UPC 10041224456287 (carton) and 04122456280 (can), PRODUCT OF PERU --   Packed Exclusively For: ROLAND FOODS, LLC, New York, NY 10070
Possible presence of glass fragments in the product lots.
Lot #s 427, 428, 432, 437; Production Codes:  G1 MSS 1 P0929 and G1 MSS 2 P092 (code is ink jet printed on the top of the can)
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Blood products,  in which labeling/labels applied to blood unit or product incorrect or missing information, were distributed.
Apheresis Plasma Frozen within 24 hours After Phlebotomy
Blood products, in which labeling/labels applied to blood units or products incorrect or missing information, were distributed.
The American National Red Cross - Southern Region
Blood product, for which donor eligibility was inadequately determined, was distributed.
Dietz & Watson Brand Italian Sub 7.3 oz bag
Potential for glass fragments due to suppliers raw material recall
Shaw's Brand Market Fresh Eggplant & Cheese Wrap, 10.0 oz packaged in plastic inside a paper open box
Dunkin Donuts Brand Italian Sub, Net Wt 7.7 oz packaged in   Bag, Clear View
Shaw's Brand Market Fresh Turkey & Roasted Red Peppers on Wheat, 5.4 oz. packaged in a wedge container
Dietz & Watson Brand Roasted Veggie White Tortilla Wrap  - 9.68 oz wrapped in plastic in a open paper box
Shaw's Brand Market Fresh Shaw Market Fresh Italian Sub, 8.3 oz. wrapped in plastic in open paper box container
US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.
EndoWrist Stapler 45 and Stapler 30 instruments used on the  da Vinci Xi systems (IS4000)  with p5 software.    General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical  procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Philips and Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501  a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
X-Ray Diagnostic Table, Model No. YSF-300  Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
Report of unintentional movement of table to reverse tilting.
Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
Lot Numbers:  C33xx  C34xx  C35xx  (xx denotes sublots)
CF InPlex ASR Card; Catalog Number: 95-0501.
Lot Numbers:  U34xx  U35xx  (xx denotes sublots)
Becton, Dickinson and Company, BD Biosciences
Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.
BD Trucount Absolute Counting Tubes:  Model number: 340334  IVD;    BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
Model: 340334;  Manufacaturing lot: 534964
Washed Red Blood Cells, Leukocytes Reduced, Irradiated
RBC product, not prepared in accordance with specifications, was distributed.
Blood product, collected from a donor who traveled within one year to a malarial endemic area, was distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Misbranded Red Blood Cells were distributed.
Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
Radionuclide Radiation Therapy System    Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile;  Catalog ID # 02.221.462S  Indicated for fixation of various long bones.
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
Lot Number 5539094, Catalog ID # 02.221.462S  Manufacture date 07/02/2007  Expiration date 05/31/2012
Distributed to 1 consignee located in the United States.
reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS)      Product Usage:  The reVive Light Therapy Pain Relief Device is a device designed to deliver LED light spectrum in 880nm and 660nm directly into the body tissue to increase circulation and temporarily relieve pain associated with muscle spasms, arthritis, general aches and strains.
Incorrect Power Supply in the package, rendering the device inoperable.
Manufactured between 12/15/2015 and 12/28/2015 for specific lot #1052
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar  Cat. Number 221291, 	Lot Number	6034889, Exp. Date : April 20, 2016  Product is sold in cartons of 100 plates each.     Product Usage:  Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes.  The device is a non-sterile prepared plated media.
Cat. Number	Lot Number  221291	                    6034889
Blood product, collected from a donor who did not have a complete physical examination, was distributed.
Taste of Inspirations Edamame Rangoon 9 oz . carton, frozen  UPC: 072543998453
Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.
Blood product, collected from a donor who was previously deferred, was distributed.
HCSC-Blood Center dba as Miller-Keystone Blood Center
Blood product, collected from donors for whom donor suitability was not adequately determined, was distributed.
US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA
SOMATOM Force, Computed Tomography x-ray system     intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected).  There is also a risk of a potential misdiagnosis in using this protocol for surgery planning.  Investigations revealed an incorrect parameterizatio
Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Distributed in Germany, U.A.E., Hungary and Brazil.
Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.
Blood Product collected from a donor who traveled to a malarial endemic area was distributed.