Mung bean sprouts are packaged 1 lb., 5 lbs., 10 lbs., 15 lbs., or 30 lbs. per plastic bag.
Environmental sampling conducted by the FDA found contamination with Listeria monocytogenes.
YumEarth Organics Gummy Bears and Gummy Worms Net Wt. 15 oz.   Distributed by Yummy Earth, Ramsey, NY 07446  UPC 810165018273
Gummy Worms and Gummy Bears are labeled incorrectly in that the outer package lists 11 mg carbohydrates and the individual packages lists 18 mg carbohydrates.
YumEarth Organics Gummy Bears 5 oz.  Distributed by YummyEarth Inc., Ramsey, NJ 07446  UPC 810165018310
YumEarth Organics Gummy Worms Net Wt. 5 oz.  Distributed by YummyEarth Inc., Ramsey, NJ 07446  UPC 810165018259
Nationwide to include Puerto Rico.  Outside the US to include:  Australia, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Sri Lanka, Sweden, Thailand, Turkey , United Kingdom (Great Britain).
PerCoBa 1, Colostral Whey, Dietary Supplement, Colostral Whey Protein 6.4%.  Net Contents:  4 oz.  Immuno-Dynamics, Inc. , PO Box 544 Perry, Iowa  50220
The PerCoBa brand and Synertek brand Colostrum product labels should state contains milk.
PerCoBa Colostrum Capsules, Dietary Supplement, Colostrum (bovine) 1g.  120 capsules.  UPC 90576-00011.  Allergen statement:  contains dairy.  Distributed by:  Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809.
Colostrum Powder, Dietary Supplement, Allergen statement:  contains dairy.  Colostrum (bovine) packaged in the following sizes and brand names:    1.  PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099.  3,000 mg Colostrum (bovine) per 2 teaspoons.   Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809;     2. PerCoBa Extra Edge Net Weight 250 grams, UPC 90576-00001.  3,000 mg Colostrum (bovine) per 2 teaspoons.     Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI  53809.;     3.  Synertek Balanced Pure, 8.8 ounces, UPC 09408-29292.  1,500 mg Colostrum (bovine) per 1 teaspoon.  Distributed by Synertek Colostrum, Inc., Cheyenne, WY  82009.
250 gram jars -  2,532 units.  150 gram jars - 68 units. 8.8 ounce jars - 11,008 units
Colostrum Lozenges, Dietary Supplement,  Colostrum (Bovine) 200mg.  Allergen statement:  contains dairy.   Packaged in the following sizes and Brand names:    1.  PerCoBa,  UPC 90576-00006.  100 Lozenges  Distributed by:  Immuno-Dynamics, Inc., Fennimore, WI  53809;     2.  Synertek, UPC 90576-00007.  100 lozenges.  Distributed by:  Synertek Colostrum, Inc., Cheyenne, WY  82009.
PerCoBa 3,310 units.  Synertek 9,468 units.
PerCoBa Whey Protein Isolate with Colostrum, Dietary Supplement.  Net Weight:  1 kg (2.2 lbs), Colostrum 3,000 mg.  UPC 90576-00009.  Immuno-Dynamics, Inc., 18000 Dodge Street, Fennimore, WI  53809.
Teriyaki hot smoked Atlantic salmon,   Teriyaki hot smoked King salmon,    Teriyaki hot smoked Sockeye salmon,   Teriyaki hot smoked salmon (no species listed).    Product was packed in bulk cases, 10 lbs. each, sold in bulk bin. There are no retail packages and NO UPC.
distributed 1533.89 lbs. to consignee and sold 138.91 lbs. on site
Teriyaki hot smoked Atlantic salmon, Teriyaki hot smoked King salmon,  Teriyaki hot smoked Sockeye salmon, and Teriyaki hot smoked salmon (no species listed)  are recalled due to undeclared wheat and soy sauce.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
US Nationwide in the states of CA, IL, MA, SC, TX
NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF   Catalog No. 601319810, UPN Product No. H7496013198101    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire.
NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111    Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.
The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.
ARMOUR MEAT BOLOGNA, packaged in deli bag.  This is a deli service item.
Product may have been sliced on the same equipment where the mortadella with pistachios was sliced.
Deli items sold from 1/20/16 to 2/3/16 at the 71 affected clubs (see distribution list).
D&W LOW SALT BOLOGNA, packaged in deli bag.  This is a deli service item.
D&W Smoked Ham All Natural, packaged in a deli bag.  This is a deli service item
WF Sandwich Ring substitute Roast Beef.  This is a deli service item
WF PASTRAMI, sold in a deli bag.  This is a deli service item
HORMEL COOKED HAM, sold in a deli bag.  This is a deli service item
CITTERIO HOT CAPICOLLA, sold in a deli bag.  This is a deli service item
WF Black Forest Ham, sold in a deli bag.  This is a deli service item
3FT American Substitute Turkey.  This is a deli service item
Citterio Sweet Capicolla, sold in a deli bag.  This is a deli service item
APPLEGATE Honey Maple Turkey, packaged in deli bag.  This is a deli service item.
DELI SANDWICH RING WF CPREP.  This is a deli service item
THE PREP ENTERTAINER.  This is a deli service item
CITTERIO PROSCIUTTO, sold in a deli bag.  This is a deli service item
WF Lighter Fare substitute Turkey.  This is a deli service item
WF Entertainer Platter.  This is a deli service item
WF Low Sodium Turkey, sold in a deli bag.  This is a deli service item
3FT American Hero.  This is a deli service item
WF Oven Honey Chicken, sold in a deli bag.  This is a deli service item
CITTERIO CHORIZO, sold in a deli bag.  This is a deli service item
D&W MAPLE HONEY TURKEY, packaged in deli bag.  This is a deli service item.
D&W Sandwich Ring substitute Roast Beef.  This is a deli service item
APPLEGATE HAM BLACK FOREST, packaged in deli bag.  This is a deli service item.
WF Croissant Platter substitute Roast Beef.  This is a deli service item
WF Buffalo Chicken , sold in a deli bag.  This is a deli service item
D&W GOURMET LITE HAM, packaged in deli bag.  This is a deli service item.
WF SMOKED TURKEY, sold in a deli bag.  This is a deli service item
ESSKAY MEAT BOLOGNA, sold in a deli bag.  This is a deli service item
WF CORNED BEEF, sold in a deli bag.  This is a deli service item
ITALIAN MEAT PLATTER.  This is a deli service item
CITTERIO GENOA SALAMI, sold in a deli bag.  This is a deli service item
WELLSLEY FARMS ROAST BEEF, sold in a deli bag.  This is a deli service item
CITTERIO HARD SALAMI, sold in a deli bag.  This is a deli service item
D&W Gourmet LITE Turkey, packaged in deli bag.  This is a deli service item.
D&W Black Forest Turkey, packaged in deli bag.  This is a deli service item.
D&W Sandwich Ring.  This is a deli service item
EL TORO CUBAN PORK, sold in a deli bag.  This is a deli service item
WF Light Platter.  This is a deli service item
Cittero Mortadella, packaged in deli bags.  This is a deli service item.
Product contains undeclared tree nuts (pistachios).
CITTERIO PEPPERONI, sold in a deli bag.  This is a deli service item
D&W OLIVE LOAF, packaged in deli bag.  This is a deli service item.
ITALIAN SANDWICH RING.  This is a deli service item
APPLEGATE ROASTED TURKEY, packaged in deli bag.  This is a deli service item.
Wellsley Farms Deli Sandwich Ring.  This is a deli service item
SAUGY NATURAL CASING FRANKS, sold in a deli bag.  This is a deli service item
D&W Black Pepper Turkey, packaged in deli bag.  This is a deli service item.
Kunzler Sweet Bologna, sold in a deli bag.  This is a deli service item
ESSKAY BBQ LOAF, sold in a deli bag.  This is a deli service item
WF Sandwich Ring substitute Turkey.  This is a deli service item
3FT Italian Hero.  This is a deli service item
WELLSLEY FARM HONEY TURKEY. This is a deli service item
D&W Signature Platter.  This is a deli service item
Croissant Sandwich Platter.  This is a deli service item
D&W Rotissere Chicken Breast, packaged in a deli bag.  This is a deli service item
APPLEGATE SLOW COOKED HAM, packaged in deli bag.  This is a deli service item.
Krakus Imported Polish Ham, sold in a deli bag.  This is a deli service item
D&W SRIRACHA CHICKEN, packaged in deli bag.  This is a deli service item.
Harvestland Honey Roasted Turkey, sold in a deli bag.  This is a deli service item
DAK HAM, sold in a deli bag.  This is a deli service item
D&W BEEF BOLOGNA, packaged in deli bag.  This is a deli service item.
D&W LONDON BROIL ROAST BEEF, packaged in deli bag.  This is a deli service item.
ESSKAY LS FF HAM, sold in a deli bag.  This is a deli service item
D&W HOME TURKEY BREAST, packaged in deli bag.  This is a deli service item.
D&W BBQ CHICKEN, packaged in deli bag.  This is a deli service item.
D&W BUFFALO CHICKEN, packaged in deli bag.  This is a deli service item.
3FT American Substitute Roast Beef.  This is a deli service item
D&W BRAUNSCHWEIGER, packaged in deli bag.  This is a deli service item.
Harvestland Roasted Turkey, sold in a deli bag.  This is a deli service item
KUNZLER LEBANON BOLOGNA, sold in a deli bag.  This is a deli service item
D&W PEPPERED HAM, packaged in deli bag.  This is a deli service item
WF Honey Ham.  This is a deli service item
Worldwide Distribution.  US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Complaints that the cannula bent/broke during surgery.
VPro Raw Plant Protein, Mocaccino. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving).
Total product including all flavors: 17,730 total units
VPro Raw Plant Protein, Natural. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 2 lb (30 serving).
VPro Raw Plant Protein, Chocolate. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving).
VPro Raw Plant Protein, Vanilla. Packaged in a plastic bottle with green, white, and black adhesive label.  Packaged in 1 lb (15 serving) and 2 lb (30 serving).
Philips Electronics North  America Corporation
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima  A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim  A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of:  Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and  United Kingdom.
Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)     Model Number: MOL2850, MOL1451, MOL1452, MOL1455
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)    Model Number: MOL2150, MOL1451, MOL1452, MOL1455
Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)     Model Number: MOL2650, MOL1451, MOL1452, MOL1455
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
Defective Delivery System: Product may contain leaking capsules.
New York, New Jersey, Connecticut, Massachusetts, Pennsylvania, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Kentucky, Ohio, Illinois, Michigan, Missouri, Alabama, Arkansas, Mississippi, Texas, and Puerto Rico.
Chef Hon brand STEAMED BUNS WITH SEAFOOD MARINATED IN XO-SAUCE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00163 0, KEEP FROZEN --- Peking Food LLC Brooklyn, NY
Undeclared eggs from component used in production of the finished product.
Lot numbers: 16021 (BEST BEFORE 01/21/17), 15348 (Best Before 12/14/16), 15337 (BEST BEFORE 12/3/16), 15271 (BEST BEFORE 9/28/16), 15240 (BEST BEFORE 8/28/16), 15176 (BEST BEFORE 6/25/16), and 15120 (BEST BEFORE 4/30/16).  -- The lot and BEST BEFORE code is printed on the front of the package.
Chef Hon brand STEAMED BUNS WITH SEAFOOD & VEGETABLE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00156 2, Product Code # 69, KEEP FROZEN --- Peking Food LLC Brooklyn, NY
Lot numbers: 16021 (BEST BEFORE 01/21/17), 15348 (Best Before 12/14/16), 15337 (BEST BEFORE 12/3/16), 15271 (BEST BEFORE 9/28/16), 15240 (BEST BEFORE 8/28/16), 15176 (BEST BEFORE 6/25/16), and 15120 (BEST BEFORE 4/30/16).  -- The lot and BEST BEFORE date is printed on the front of the package.
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish)  Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
NEL- GBS Medium (Broth  3 ml Fill 13 x 100 mm Screw Cap Tube  Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
All product was shipped to KY and further distributed Nationwide
Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Outer Cases and Cartons Lot #: 13650, EXP 06/2017; Blisters Lot #: 13560, EXP 06/2017
Oak Haven, Inc dba Country Life Natural Foods.
AR, CA, FL, IA, IL, IN, MI, MN, MO, OK, SC, SD, TN, and WI
Country Life Natural Foods Labeled SHELLED PISTACHIOS RAW NET WT. 2lb (906 g) plastic bags item 030244 and Batch 1357    batch number 1357 in the lower left corner of the label
Country Life Natural foods shelled raw pistachios, sold in 2 lb bags and SAM International labeled 30lb boxes because it has the potential to be contaminated with Salmonella.
SAM International RAW WHOLE PISTACHIO 80%VP Labeled 30 pound box
Worldwide  distribution to AZ , CA , FL , GA ,  IL , MI , MN , NM , NY , OH , TX , UT and Internationally to Germany and the United Kingdom.    6 distributed to OUS accounts: Germany, and the United Kingdom
Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin should be stored in a cool, dry place
Multiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.
Sweetwater Sprouts 100% Pure Sprouted Mung Bean packaged in the following configurations:  8 oz. plastic bags packed 10 per case;  16 oz. plastic bags packed  in cases of 5 or 10;  5 lb. bulk case;  10 lb. bulk case.     The product is shipped in cardboard cases labeled with product and lot number. The responsible name on the label is Sweetwater Farms, Inman, KS 67546.
Sprouts are potentially contaminated with Salmonella
Sweetwater Sprouts 100% Pure Sprouted Alfalfa packaged in the following configurations:     4 oz. plastic bags (UPC 7 56733 00104 2) packed 12 per case;  16 oz. (1 lb.) plastic bags;  and 5 lb. bulk boxes    The product is shipped in cardboard cases labeled with product and lot number. The responsible name on the label is Sweetwater Farms LLC, Inman, KS 67456.
Sweetwater Sprouts100% Pure Sprouted Clover packaged in plastic bags and shipped in cardboard cases labeled with product, Net Wt. 5 lb. and lot number. The responsible name on the label is Sweetwater Farms, Inman, KS 67546.
US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
phoenix micrornelx and nanomelx cabinet x-ray systems
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, collected from an ineligible donor, were distributed.
MicroAire has initiated a recall on product  PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery.    Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; and, the country of Canada.
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation.     Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
The firm received a complaint of the battery exploding while recharging.
Fresenius Medical Care Renal Therapies Group, LLC
US Nationwide Distribution including states of: AZ, CA, CT, DC, GA, IL, IN, MI, MN, MO, MS, NY, OH, PA, SC, SD, TX, and WA.
Fresenius Hemoflow F3 Dialyzer  Part Number: 0520165A    Indicated for Acute and Chronic Hemodialysis
Dialyzer header leak due to possible improper torque
The firm distributed the recalled product to domestic firms  and one firm located in Australia. The company in Austraila is Phyto-thereapy PT LTD-PO BOX 5018, Elanra Heights NSW 2100 Australia.
GSN organic Mediterranean Blend packaged in 44 lb. polyethylene liner inside of a cardboard box.
220 pounds distributed to customers in bulk
FDA sample of Spinach powder came back positive for Salmonella.
Air dried Organic Spinach Powder  packaged in 50 lb. polyethylene liner inside of a cardboard box.
4398.59 pounds distributed to customers in bulk
Whole Foods Market Maytag Blue Cheese, Maytag Blue Raw Milk, Maytag Iowa Blue Cheese cut and wrapped in clear plastic wrap, Dist. by Whole Foods Market 550 Bowie Street Austin, TX 78703, PLU: 0293308
Possible contamination with Listeria monocytogenes.
PLU numbers beginning with 293308 with sell by dates of 1/20/2016 through 3/21/2016.
Worldwide Distribution-US (nationwide) including Puerto Rico  and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110.  Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
2,101 Total units (1,043 domestically & 1,058 internationally)
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Product Codes: 6802413, 6802915 (Refurbished)  Serial numbers: J56000024 - J56002387
distributed in OR and WA and sold via mail orders to customers in FL, GA, and OH
Wild Smoked Pink Salmon is recalled due to a positive test result for Listeria monocytogenes.
VA Kit Roasting Brussel Sprouts, Item #72893.  Each case contains 2/6.15 lb. bags.  The UPC is 0 20728 72893 2
VA Kit Roasting Brussel Sprouts, Item #72893, is recalled due to a possible exposure to walnut.
U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ.    Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
STD GK258, AME Standard Kit 44    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
STD KIT GK260, Standard Set 360 Z    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
CA500 Epix Universal Clip Applier    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
STD KIT GK213, AME Standard Kit 15    Product Usage:   The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Worldwide Distribution - US Distribution
Ellex Medical Fixed eye Safety filters Model  Integre S LP5532.    The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment  laser light to physician eyes while the  aiming beam to remain visible.      .
The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only.  Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.
US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Novo Bnei Darom Green Olives in Jar, 48 cases, 6 jars, 1.04kg, UPC Code 7290002016175
International Trading & Import Inc. dba Nuts & More is recalling Novo Bnei Darom Green Olives because it contains an unapproved pesticide (Chlorpyrifos)
DUTCH FARMSTEAD CHEESE SMOKED PLAIN GOUDA
Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
Fresenius 2008 Series Hemodialysis  Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:  Models:  Fresenius 2008K and 2008K2 Dialysate Delivery System  Fresenius 2008K@home Hemodialysis Machine with bibag System  2008T Hemodialysis Machine
US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.
All instrumentation associated with the Prelude PF Resurfacing Knee System.
All Lots of All Prelude PF instrumentation part numbers.     Part Number	Description  110004338:	No. 1 Femoral Trial, Left   110004248:	No. 1 Femoral Trial, Right   110004339:	No. 2 Femoral Trial, Left  110004250:	No. 2 Femoral Trial, Right  110004344:	No. 3 Femoral Trial, Left  110004252:	No. 3 Femoral Trial, Right  110004342:	No. 4 Femoral Trial, Left  110004254:	No. 4 Femoral Trial, Right  110004341:	No. 5 Femoral Trial, Left  110004256:	No. 5 Femoral Trial, Right  110004337:	No. 6 Femoral Trial, Left  110004258:	No. 6 Femoral Trial, Right  110004340:	No. 6W Femoral Trial, Left  110004260:	No. 6W Femoral Trial, Right  110004343:	No. 7W Femoral Trial, Left  110004262:	No. 7W Femoral Trial, Right  110004345:	No. 8W Femoral Trial, Left  110004264:	No. 8W Femoral Trial, Right  110004105:	No. 1 Drill Guide, Left   110004106:	No. 1 Drill Guide, Right  110004107:	No. 2 Drill Guide, Left   110004108:	No. 2 Drill Guide, Right  110004109:	No. 3 Drill Guide, Left   110004110:	No. 3 Drill Guide, Right  110004111:	No.4 Drill Guide, Left  110004112:                     No.4 Drill Guide, Right  110004113:	No. 5 Drill Guide, Left  110004114:	No. 5 Drill Guide, Right  110004115:	No. 6 Drill Guide, Left  110004116:	No. 6 Drill Guide, Right  110004117:	No. 6W Drill Guide, Left  110004118:	No. 6W Drill Guide, Right  110004119:	No. 7W Drill Guide, Left  110004120:	No. 7W Drill Guide, Right  110004121:	No. 8W Drill Guide, Left  110004122:	No. 8W Drill Guide, Right  010001763:	25MM Reamer  010001768:	31MM Reamer  110004151:	25MM Stop Collar  110004165:	31MM Stop Collar  110007428:	Stop Collar Push Button  110004170:	2.1MM Guide Pin  110004169:	Trial Remover  110004172:	Impactor Handle  110007398:	15 Degree Rasp  597004:	                      Instrument Case  110018820:	25MM Peek Bushing  110018821:	31MM Peek Bushing
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO,   NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty.  REF 42-5114-005-14
The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides.  One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty.  REF 42-5114-008-18
The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case .
Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102. .
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Superpotent Drug: one ingredient was found to be above assay specification.
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.
Nationwide Distribution in the states of  AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV.
Guardian II Hemostasis Valve, models 8210 and 8211.  The following models are only available Outside the US:  FH101, FH101-T, FH101-25, and FH101-50.      Product Usage:  The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system.  The devices have two seals:  the low-pressure seal, and the high-pressure seal.  Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves.  The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
Worldwide Distribution - US Nationwide in the states of SC,  NC and the countries of Australia, Canada, France. Germany, Japan and Turkey.
SIGNA Pioneer MR Systems    Product Usage:  The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Ferrous material in the  SIGNA Pioneer Table Control Box (TCB)  could cause unexpected attraction to the MR system's high strength  magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from  the magnetic field. There have been no events reported as a result of this issue. Clinical  scanni
Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of  Canada and Switzerland.
Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E    Product Usage:  The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
500 units distributed in USA,  and 35 units distributed OUS
Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.
Titanium Low Profile Neuro Screw, Self-Drilling, 3mm, part number # 400.833, Lot numbers: 9960359, 9962300, 9967875
150 units distributed in US, 1439 units distributed OUS (foreign)
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Labeling: Label Error on Declared Strength
American Red Cross Blood Services Heart of America Region
Apheresis Red Blood Cells, Leukocytes Reduced
Blood product, for which quality control testing was not performed, was distributed.
Blood products, lacking product quality control testing, were distributed.
U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only.  Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Source Plasma was inappropriately distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Walter L. Shepeard Community Blood Center, Inc.
Blood products, collected from an ineligible donor, were distributed.