The Recall Desk

Archive

April 2016 recalls

764 recalls were announced in April 2016.

What the numbers show

Critical
20
Severe
108
High
373
Moderate
207
Low
56

Of the 764 recalls this month scored against our rubric, 3% are Critical, 14% are Severe.

501–600 of 764

  • HighFDA (Devices)·Z-1274-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa Group A Strep Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.

    Product
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16E034000·2016-04-13

    Nitrous Outlet Recalls Nitrous Solenoid Valves Due to Welding Defect

    Nitrous Outlet is recalling specific .122 Nitrous Solenoid valves due to improper welding that may cause the piston to eject under pressure, posing an injury risk.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0960-2016·2016-04-13

    Bj's Wholesale Club Recalls Italian Sandwich Rings for Cross-Contact Risk

    Bj's Wholesale Club is recalling Italian Sandwich Rings sold in eight states because they may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    ITALIAN SANDWICH RING. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0979-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Roast Beef for Potential Allergen Cross-Contact

    BJ's Wholesale Club is recalling deli roast beef that may have been sliced on equipment used for mortadella with pistachios, posing a risk to those with tree nut allergies.

    Product
    WF Sandwich Ring substitute Roast Beef. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0974-2016·2016-04-13

    BJ's Wholesale Club Recalls WF Light Platter Due to Cross-Contact Risk

    BJ's Wholesale Club is recalling WF Light Platters sold in eight states because they may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    WF Light Platter. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1017-2016·2016-04-13

    PerCoBa Whey Protein Isolate Recalled for Missing Milk Allergen Labeling

    Immuno-Dynamics, Inc. is recalling PerCoBa Whey Protein Isolate with Colostrum because the labels fail to state that the product contains milk.

    Product
    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.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0930-2016·2016-04-13

    Bj's Recalls Applegate Slow Cooked Ham Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling Applegate Slow Cooked Ham sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    APPLEGATE SLOW COOKED HAM, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0936-2016·2016-04-13

    Bj's Recalls D&W Black Pepper Turkey Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Black Pepper Turkey deli items that may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    D&W Black Pepper Turkey, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1016-2016·2016-04-13

    Immuno-Dynamics Recalls PerCoBa Colostrum Supplement for Missing Milk Labeling

    Immuno-Dynamics is recalling PerCoBa and Synertek colostrum supplements because the labels fail to state that the products contain milk.

    Product
    PerCoBa 1, Colostral Whey, Dietary Supplement, Colostral Whey Protein 6.4%. Net Contents: 4 oz. Immuno-Dynamics, Inc. , PO Box 544 Perry, Iowa 50220
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1024-2016·2016-04-13

    Bay Valley Foods Recalls Crispers Honey Lime Dressing for Undeclared Egg

    Bay Valley Foods is recalling Crispers Honey Lime Dressing because it contains egg, an undeclared allergen. The product was distributed in Florida.

    Product
    Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0994-2016·2016-04-13

    BJ's Wholesale Club Recalls 3FT Italian Hero Deli Sandwiches

    BJ's Wholesale Club is recalling 3FT Italian Hero deli sandwiches sold in eight states because they may have been sliced on equipment used for mortadella with pistachios.

    Product
    3FT Italian Hero. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0956-2016·2016-04-13

    BJ's Wholesale Club Recalls Harvestland Honey Roasted Turkey Deli Meat

    BJ's Wholesale Club is recalling Harvestland Honey Roasted Turkey sold in deli bags in eight states due to potential cross-contact with pistachio-containing mortadella.

    Product
    Harvestland Honey Roasted Turkey, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0937-2016·2016-04-13

    Bj's Wholesale Club Recalls D&W Braunschweiger Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Braunschweiger because it may have been sliced on equipment used for mortadella with pistachios, posing a potential allergen risk.

    Product
    D&W BRAUNSCHWEIGER, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0947-2016·2016-04-13

    BJ's Wholesale Club Recalls D&W Signature Platter Due to Cross-Contact Risk

    BJ's Wholesale Club is recalling D&W Signature Platters because they may have been sliced on equipment used for mortadella with pistachios, posing an allergen cross-contact risk.

    Product
    D&W Signature Platter. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0993-2016·2016-04-13

    BJ's Wholesale Club Recalls 3FT American Hero Deli Item

    BJ's Wholesale Club is recalling 3FT American Hero deli items sold in eight states due to potential cross-contact with mortadella containing pistachios.

    Product
    3FT American Hero. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0969-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Buffalo Chicken for Cross-Contact Risk

    BJ's Wholesale Club is recalling deli Buffalo Chicken sold in eight states because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    WF Buffalo Chicken , sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0988-2016·2016-04-13

    Bj's Recalls Citterio Pepperoni Sliced on Shared Deli Equipment

    Bj's Wholesale Club is recalling Citterio Pepperoni sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    CITTERIO PEPPERONI, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1343-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.

    Product
    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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2016·2016-04-13

    Philips Recalls eValueMed Infant Heel Warmers and Transport Mattresses

    Philips is recalling eValueMed infant heel warmers and transport mattresses because they lack expiration dates and warnings about overheating risks.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2016·2016-04-13

    Synthes Recalls Titanium Low Profile Neuro Screws Due to Thread Defect

    Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.

    Product
    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 sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0995-2016·2016-04-13

    BJ's Wholesale Club Recalls American Substitute Turkey Deli Items

    BJ's Wholesale Club is recalling American Substitute Turkey deli items sold in eight states due to potential cross-contact with pistachio-containing mortadella.

    Product
    3FT American Substitute Turkey. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0949-2016·2016-04-13

    BJ's Wholesale Club Recalls D&W Smoked Ham Due to Cross-Contact Risk

    BJ's Wholesale Club is recalling D&W Smoked Ham All Natural because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W Smoked Ham All Natural, packaged in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0953-2016·2016-04-13

    Bj's Recalls Esskay BBQ Loaf Due to Potential Cross-Contact

    Bj's Wholesale Club is recalling Esskay BBQ Loaf sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    ESSKAY BBQ LOAF, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0983-2016·2016-04-13

    Bj's Wholesale Club Recalls Deli Sandwich Rings for Cross-Contact Risk

    Bj's Wholesale Club is recalling deli sandwich rings that may have been sliced on equipment used for mortadella with pistachios, posing a potential allergen cross-contact risk.

    Product
    DELI SANDWICH RING WF CPREP. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0961-2016·2016-04-13

    Bj's Recalls Krakus Imported Polish Ham Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling Krakus Imported Polish Ham because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    Krakus Imported Polish Ham, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0971-2016·2016-04-13

    BJ's Wholesale Club Recalls Roast Beef Deli Item for Cross-Contact Risk

    BJ's Wholesale Club is recalling deli roast beef items that may have been sliced on equipment used for mortadella with pistachios, posing a potential allergen cross-contact risk.

    Product
    WF Croissant Platter substitute Roast Beef. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0965-2016·2016-04-13

    Bj's Wholesale Club Recalls Deli Service Items for Cross-Contact Risk

    Bj's Wholesale Club is recalling deli service items that may have been sliced on equipment used for mortadella with pistachios, posing a potential allergen cross-contact risk.

    Product
    THE PREP ENTERTAINER. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0990-2016·2016-04-13

    Bj's Wholesale Club Recalls Citterio Genoa Salami for Cross-Contamination Risk

    Bj's Wholesale Club is recalling Citterio Genoa Salami because it may have been sliced on equipment used for mortadella with pistachios, posing an allergen risk.

    Product
    CITTERIO GENOA SALAMI, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0931-2016·2016-04-13

    Bj's Recalls Armour Meat Bologna Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling Armour Meat Bologna deli items that may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    ARMOUR MEAT BOLOGNA, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0964-2016·2016-04-13

    BJ's Wholesale Club Recalls Saugy Natural Casing Franks for Allergen Cross-Contact

    BJ's Wholesale Club is recalling Saugy Natural Casing Franks sold in deli bags in eight states because they may have been sliced on equipment used for mortadella with pistachios.

    Product
    SAUGY NATURAL CASING FRANKS, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0972-2016·2016-04-13

    Bj's Wholesale Club Recalls WF Entertainer Platter Deli Items

    Bj's Wholesale Club is recalling WF Entertainer Platter deli items sold in eight states because they may have been sliced on equipment used for mortadella with pistachios.

    Product
    WF Entertainer Platter. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0967-2016·2016-04-13

    BJ's Wholesale Club Recalls Wellsley Farms Roast Beef for Cross-Contact Risk

    BJ's Wholesale Club is recalling Wellsley Farms Roast Beef sold in deli bags in eight states due to potential cross-contact with mortadella containing pistachios.

    Product
    WELLSLEY FARMS ROAST BEEF, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0970-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Corned Beef for Cross-Contact Risk

    BJ's Wholesale Club is recalling deli corned beef that may have been sliced on equipment used for mortadella with pistachios, posing a potential allergen exposure risk.

    Product
    WF CORNED BEEF, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1347-2016·2016-04-13

    GE Medical Systems Recalls SIGNA Pioneer MR Systems Due to Ferrous Material Risk

    GE Medical Systems is recalling 16 SIGNA Pioneer MR systems because ferrous material in the Table Control Box could cause unexpected attraction to the magnetic field during servicing, posing a risk of serious injury to personnel.

    Product
    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, coron
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16738·2016-04-13

    Yamaha Recalls Utility Vehicles Due to Throttle Cable Freeze Hazard

    Yamaha is recalling about 7,000 model year 2016 YXZ1000R utility vehicles because water in the throttle cable can freeze, preventing the throttle from returning to idle and causing loss of control.

    Product
    Yamaha Recreational Off-Highway Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16142·2016-04-13

    Rollerblade USA Recalls Inline Skating Helmets Due to Head Injury Hazard

    Rollerblade USA is recalling about 500 Maxxum inline skating helmets because the plastic shell can crack, causing the helmet to shift and potentially result in head injuries.

    Product
    Rollerblade inline skating helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2016·2016-04-13

    Laserex Systems Recalls Ellex Medical Fixed Eye Safety Filters

    Laserex Systems Inc. is recalling 74 Ellex Medical Fixed Eye Safety Filters due to a design error in the optic adaptor that may compromise eye protection.

    Product
    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. .
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0944-2016·2016-04-13

    Bj's Recalls D&W Maple Honey Turkey for Potential Cross-Contact

    Bj's Wholesale Club is recalling D&W Maple Honey Turkey deli items that may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W MAPLE HONEY TURKEY, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1324-2016·2016-04-13

    Fresenius Hemoflow F3 Dialyzer Recalled for Potential Header Leak

    Fresenius Medical Care is recalling 1,650 Hemoflow F3 Dialyzers due to a potential header leak caused by improper torque.

    Product
    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2016·2016-04-13

    Therakos CELLEX Photopheresis System Recalled for Tubing Leaks

    Therakos Inc is recalling 729 units of the CELLEX Photopheresis System, Lot D342, due to an increased trend in tubing leaks within the pump tubing organizer.

    Product
    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0963-2016·2016-04-13

    Bj's Recalls Kunzler Lebanon Bologna Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling Kunzler Lebanon Bologna because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    KUNZLER LEBANON BOLOGNA, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0805-2016·2016-04-13

    Meditech Formula 1 Injection Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling 1,320 vials of Formula 1 Injection because the active ingredient expired before the labeled Beyond Use Date.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0933-2016·2016-04-13

    Bj's Recalls Deli BBQ Chicken Due to Potential Cross-Contact

    Bj's Wholesale Club is recalling D&W BBQ Chicken deli items that may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W BBQ CHICKEN, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-1014-2016·2016-04-13

    PerCoBa Colostrum Capsules Recalled for Incorrect Milk Allergen Labeling

    Immuno-Dynamics, Inc. is recalling PerCoBa Colostrum Capsules because the labels failed to state 'contains milk.' The product was distributed nationwide and internationally.

    Product
    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.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0942-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Roast Beef for Cross-Contact Risk

    BJ's Wholesale Club is recalling D&W London Broil Roast Beef sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W LONDON BROIL ROAST BEEF, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1333-2016·2016-04-13

    Karl Storz Endoscope Cleaning Brush Recalled for Fit Issues

    Karl Storz is recalling 16,908 endoscope cleaning brushes because they may not fit into the endoscope channel, preventing proper cleaning.

    Product
    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0810-2016·2016-04-13

    Purdue Pharma Recalls Intermezzo Tablets for Dissolution Failures

    Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

    Product
    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.
    Category
    Drug
    Distribution
    8 states
  • ModerateFDA (Food)·F-0981-2016·2016-04-13

    Bj's Wholesale Club Recalls Smoked Turkey Deli Slices

    Bj's Wholesale Club is recalling smoked turkey deli slices that may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    WF SMOKED TURKEY, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0815-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

    Actavis Elizabeth LLC is recalling 182,378 bottles of 30 mg Dextroamphetamine and Amphetamine tablets because they failed impurity specifications.

    Product
    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, M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1015-2016·2016-04-13

    Immuno-Dynamics Recalls Colostrum Lozenges for Allergen Labeling Error

    Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek colostrum lozenges because the labels state 'contains dairy' instead of 'contains milk.'

    Product
    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. Syner
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1331-2016·2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0935-2016·2016-04-13

    BJ's Wholesale Club Recalls D&W Black Forest Turkey Deli Meat

    BJ's Wholesale Club is recalling D&W Black Forest Turkey deli meat because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W Black Forest Turkey, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0934-2016·2016-04-13

    Bj's Recalls D&W Beef Bologna for Potential Cross-Contact

    Bj's Wholesale Club is recalling D&W Beef Bologna sold in deli bags due to potential cross-contact with mortadella containing pistachios.

    Product
    D&W BEEF BOLOGNA, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0952-2016·2016-04-13

    Bj's Wholesale Club Recalls Deli Ham Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling DAK HAM sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    DAK HAM, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0958-2016·2016-04-13

    Bj's Wholesale Club Recalls Hormel Cooked Ham for Potential Cross-Contact

    Bj's Wholesale Club is recalling Hormel Cooked Ham sold in deli bags in eight states because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    HORMEL COOKED HAM, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1340-2016·2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product information on the box differed by sides, showing conflicting part and lot numbers.

    Product
    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
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-0927-2016·2016-04-13

    Bj's Recalls Applegate Ham Black Forest Deli Items

    Bj's Wholesale Club is recalling Applegate Ham Black Forest deli items that may have been sliced on equipment used for mortadella with pistachios.

    Product
    APPLEGATE HAM BLACK FOREST, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0940-2016·2016-04-13

    Bj's Recalls D&W Gourmet Lite Ham for Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Gourmet Lite Ham sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W GOURMET LITE HAM, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0966-2016·2016-04-13

    Bj's Recalls Wellsley Farm Honey Turkey Deli Slices

    Bj's Wholesale Club is recalling Wellsley Farm Honey Turkey deli slices that may have been sliced on equipment used for mortadella with pistachios.

    Product
    WELLSLEY FARM HONEY TURKEY. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0951-2016·2016-04-13

    Bj's Recalls El Toro Cuban Pork Deli Meat

    Bj's Wholesale Club is recalling El Toro Cuban Pork deli meat because it may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    EL TORO CUBAN PORK, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0982-2016·2016-04-13

    Wellsley Farms Deli Sandwich Ring Recalled for Potential Cross-Contact

    BJ's Wholesale Club is recalling Wellsley Farms Deli Sandwich Rings sold in eight states due to potential cross-contact with mortadella containing pistachios.

    Product
    Wellsley Farms Deli Sandwich Ring. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0813-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets for Impurity Failures

    Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles distributed nationwide.

    Product
    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, M
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0975-2016·2016-04-13

    Bj's Recalls WF Lighter Fare Substitute Turkey Deli Meat

    Bj's Wholesale Club is recalling WF Lighter Fare substitute Turkey deli meat because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    WF Lighter Fare substitute Turkey. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0806-2016·2016-04-13

    Meditech Formula 3 Injection Recalled Due to Expired Active Ingredient

    Meditech Laboratories is recalling Formula 3 Injection vials because the active ingredient expired before the labeled Beyond Use Date.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2016·2016-04-13

    GE Cabinet X-ray Systems Recalled for Non-Compliance with FDA Standards

    GE Inspection Technologies is recalling 55 cabinet x-ray systems used for industrial quality control because they may not fully comply with FDA performance standards.

    Product
    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-1332-2016·2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Defect

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0986-2016·2016-04-13

    BJ's Wholesale Club Recalls Citterio Sweet Capicolla Deli Meat

    BJ's Wholesale Club is recalling Citterio Sweet Capicolla deli meat because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    Citterio Sweet Capicolla, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1325-2016·2016-04-13

    Fresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms

    Fresenius Medical Care is recalling 2008 Series hemodialysis machines because they may trigger false blood leak alarms when treating patients with Vitamin B-12.

    Product
    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 The Fresenius 2008¿ Series Machines
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1314-2016·2016-04-13

    Northeast Laboratory Services Recalls GBS Medium Tubes for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 11,720 units of GBS Medium tubes because they were marketed without FDA 510(k) clearance.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0946-2016·2016-04-13

    Bj's Wholesale Club Recalls Peppered Ham Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Peppered Ham sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W PEPPERED HAM, packaged in deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1320-2016·2016-04-13

    Cardinal Health Recalls Gomco Style Circumcision Clamp Trays Due to Labeling Error

    Cardinal Health is recalling Gomco Style Circumcision Clamp Trays because two lots were labeled as containing 1.1cm clamps but actually contained 1.3cm clamps.

    Product
    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0943-2016·2016-04-13

    Bj's Wholesale Club Recalls Deli Bologna for Potential Cross-Contact

    Bj's Wholesale Club is recalling D&W Low Salt Bologna sold in deli bags because it may have been sliced on equipment used for pistachio mortadella.

    Product
    D&W LOW SALT BOLOGNA, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1341-2016·2016-04-13

    Zimmer Persona Knee Implant Recalled for Box Labeling Discrepancy

    Zimmer Manufacturing B.V. is recalling specific Persona knee implants because the product box displayed conflicting part and lot numbers on different sides.

    Product
    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
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-0954-2016·2016-04-13

    Bj's Recalls Deli Ham Sliced on Shared Equipment

    Bj's Wholesale Club is recalling ESSKAY LS FF HAM sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    ESSKAY LS FF HAM, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-1023-2016·2016-04-13

    YumEarth Gummy Bears and Worms Recalled for Carbohydrate Labeling Error

    Yummy Earth Inc is recalling YumEarth Organics Gummy Bears and Gummy Worms because the outer and individual packages list different carbohydrate amounts.

    Product
    YumEarth Organics Gummy Bears and Gummy Worms Net Wt. 15 oz. Distributed by Yummy Earth, Ramsey, NY 07446 UPC 810165018273
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1021-2016·2016-04-13

    YumEarth Gummy Bears Recalled for Carbohydrate Labeling Error

    Yummy Earth Inc. is recalling YumEarth Organics Gummy Bears due to inconsistent carbohydrate labeling on the packaging.

    Product
    YumEarth Organics Gummy Bears 5 oz. Distributed by YummyEarth Inc., Ramsey, NJ 07446 UPC 810165018310
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1272-2016·2016-04-13

    Focus Diagnostics Recalls Simplexa HSV 1&2 Direct Amplification Discs

    Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.

    Product
    Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0984-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Roast Beef for Cross-Contact Risk

    BJ's Wholesale Club is recalling deli roast beef sold in eight states because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W Sandwich Ring substitute Roast Beef. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1329-2016·2016-04-13

    Applied Medical Recalls Epix Universal Clip Appliers Due to Loading Mechanism Defect

    Applied Medical Resources Corp is recalling CA500 Epix Universal Clip Appliers due to a potential loading mechanism nonconformance. The recall affects 1,771 units distributed in the U.S. and internationally.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0989-2016·2016-04-13

    Bj's Recalls Citterio Hot Capicolla Due to Potential Cross-Contact

    Bj's Wholesale Club is recalling Citterio Hot Capicolla because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    CITTERIO HOT CAPICOLLA, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1313-2016·2016-04-13

    Northeast Laboratory Services Recalls GBS Medium for Missing 510(k) Clearance

    Northeast Laboratory Services is recalling 9,300 units of GBS Medium because the product was marketed without FDA 510(k) clearance.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1042-2016·2016-04-13

    Novo Bnei Darom Green Olives Recalled for Unapproved Pesticide

    International Trading & Import Inc. is recalling Novo Bnei Darom Green Olives because they contain the unapproved pesticide Chlorpyrifos.

    Product
    Novo Bnei Darom Green Olives in Jar, 48 cases, 6 jars, 1.04kg, UPC Code 7290002016175
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1330-2016·2016-04-13

    Applied Medical Resources Recalls Epix Universal Clip Applier Kits

    Applied Medical Resources Corp is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1041-2016·2016-04-13

    Abbott Nutrition Recalls PediaSure Grow & Gain Vanilla Due to Sensory Changes

    Abbott Nutrition is recalling PediaSure Grow & Gain Vanilla cans because the product may have an inconsistent color, smell, taste, or texture.

    Product
    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 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0938-2016·2016-04-13

    Bj's Recalls Deli Buffalo Chicken Due to Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Buffalo Chicken deli items because they may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W BUFFALO CHICKEN, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0955-2016·2016-04-13

    BJ's Wholesale Club Recalls Esskay Meat Bologna for Cross-Contact Risk

    BJ's Wholesale Club is recalling Esskay Meat Bologna sold in deli bags because it may have been sliced on equipment used for pistachio-containing mortadella.

    Product
    ESSKAY MEAT BOLOGNA, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1321-2016·2016-04-13

    ArthroCare Recalls TOPAZ MicroDebrider Devices Due to Shelf-Life Failure

    ArthroCare Corporation is recalling 26,903 TOPAZ MicroDebrider devices because they failed to meet shelf-life requirements at their expiration dates.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0948-2016·2016-04-13

    Bj's Recalls D&W Rotisserie Chicken Breast for Cross-Contact Risk

    Bj's Wholesale Club is recalling D&W Rotisserie Chicken Breast because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W Rotissere Chicken Breast, packaged in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-0962-2016·2016-04-13

    Bj's Recalls Kunzler Sweet Bologna Due to Potential Cross-Contact

    Bj's Wholesale Club is recalling Kunzler Sweet Bologna deli items that may have been sliced on equipment used for pistachio mortadella.

    Product
    Kunzler Sweet Bologna, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1349-2016·2016-04-13

    Siemens PACS Software Recall for Incorrect Distance Measurements

    Siemens Medical Solutions is recalling 49 PACS systems because they may display incorrect distance measurements when used with certain modalities and syngo Imaging.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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