Archive
614 recalls were announced in December 2015.
Of the 614 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.
Which agencies issued them
Western Drug is recalling 7 containers of Vitamin B-Complex 100 Injection because there is a lack of assurance of sterility. The product was distributed nationwide in eight states.
Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.
Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.
Morrilton Packing Co. is recalling approximately 12,146 pounds of boneless ham products because they contain soy, a known allergen, that was not declared on the label.
DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.
Life Science Pharmacy Inc. is recalling compounded Estriol Vaginal Creams due to potential penicillin cross-contamination.
Save-A-Lot is recalling 16-ounce bags of Whole Kernel Corn Frozen Fresh because a sample tested positive for Listeria monocytogenes.
Quest Medical, Inc. is recalling specific MPS Delivery Sets used with cardiopulmonary bypass equipment due to intermittent seal failures during use.
World Variety Produce Inc. is recalling Wegman's Italian Classics Pine Nuts due to potential Salmonella contamination. The product was distributed in 23 states.
DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.
Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.
Save-A-Lot is recalling Wylwood Mixed Vegetables Steam Bags because a sample tested positive for Listeria monocytogenes. The product was distributed to specific states in the US.
Life Science Pharmacy Inc. is recalling Human Chorionic Gonadotropin (HCG) sublingual drops due to potential penicillin cross-contamination. The recall covers all lots distributed nationwide.
Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.
Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.
Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.
Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.
Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.
Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.
Land O' Lakes is recalling one lot of Kozy Shack Indulgent Salted Caramel Pudding because it may contain egg-containing Vanilla Bean Pudding cups.
VRVK Nutraceuticals is recalling Dr. Venessa's Formulas Ultimate Antioxidant Tablets because FDA inspection found undeclared milk and crustacean shellfish.
Western Drug is recalling T.C.A 30% Acid Solution because the product lacks assurance of sterility. The recall affects one container distributed nationwide.
Western Drug is recalling Procaine HCl Injection 1% and 2% because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
Halcore Group is recalling 18 model year 2015 Horton ambulances because an incorrectly installed circuit board component may cause electrical system failure, potentially disabling life-saving equipment.
Ameritrans is recalling 2012-2014 buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.
Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.
Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.
Brookshire Brothers is recalling David's Gourmet Chocolate Chunk Pecan Cookies due to plastic found in the cookie dough.
Strong America Limited is recalling Golden Smell brand Hot Pot Meat Ball Medly because it contains undeclared eggs, posing a risk to individuals with egg allergies.
Brett Anthony Foods is recalling Green Quinoa Cous Cous Salad kits because consumers found a piece of wire in the product.
Shakti Group USA LLC is recalling 39,450 lbs of ground cumin because it contains 8.0 ppm of peanut allergen. The product was distributed in New York.
Life Science Pharmacy Inc. is recalling compounded Estriol Gels because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.
Western Drug is recalling Cantharitus Multi-Mix Prep because the product lacks assurance of sterility. The recall affects all lots distributed nationwide.
Life Science Pharmacy Inc. is recalling TRI-EST Gels because they may be contaminated with penicillin.
Basler Electric is recalling about 11,900 Class 2 electric transformers because a circuit breaker may fail to trip, posing fire and electrical shock risks.
Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.
Life Science Pharmacy Inc. is recalling compounded Estriol Suppositories because they may be contaminated with penicillin. The recall covers all lots distributed nationwide.
Geritrex Corp is recalling Carbo-O-Philic 40 Gel because the FDA determined it is an unapproved new drug and misbranded.
Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars because the FDA determined they are unapproved new drugs and misbranded.
Geritrex Corporation is recalling Carbo-O-Philic 40 Cream tubes because the FDA determined the product is an unapproved new drug and misbranded.
Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.
Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.
Nephron Pharmaceuticals is recalling 32,490 cartons of Asthmanefrin Racepinephrine Inhalation Solution due to discoloration. The FDA classifies this as a Class II recall.
Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.
Nephron Pharmaceuticals is voluntarily recalling Asthmanefrin inhalation solution starter kits due to discoloration. The recall covers 47,754 cartons distributed nationwide.
Ormco is recalling Copper NiTi Preformed Archwires because the transformation temperature listed on the label is incorrect.
ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.
Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.
Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.
Northwind Pharmaceuticals is recalling 40 bottles of Prednisone 20 mg tablets because the NDC number on the container is incorrect.
Volkswagen Group of America is recalling 2012-2013 Audi A6 and A7 vehicles because the passenger air bag system may fail to deploy in a crash.
Strick Trailers is recalling 2007, 2009, and 2015 Dry Freight Van Trailers because rear impact guard gussets increase injury risk in crashes.
Kubota is recalling approximately 11,500 RTV-X1100C utility vehicles because combustible debris can contact the exhaust manifold and ignite, posing a fire hazard.
Limoss is recalling about 2,500 lithium ion battery power packs for power recliners and lift chairs because they can overheat and pose a fire hazard.
Jofran is recalling about 300 Boulder Ridge dining tables because stress fractures in the cement tops can cause the table to break. No injuries have been reported.
Volkswagen is recalling 904 2015 Audi A3 Cabriolets because incorrectly stitched seat covers may prevent side air bags from deploying properly in a crash.
Grand Design is recalling 2016 Momentum trailers because incorrect weight labels may cause owners to overload the vehicle, increasing crash risk.
Technical Consumer Products is recalling specific 14-watt LED PAR38 lamps sold at Walmart and electrical distributors due to a risk of electric shock in wet locations.
Daimler Trucks North America is recalling 2013-2015 Freightliner Cascadia CNG vehicles because hot exhaust near the pressure relief device may cause gas release and fire.
Polaris is recalling 2015 GEM electric vehicles because seat belt retractors may fail, preventing proper occupant restraint in a crash.
Honda is recalling 2010, 2012, and 2013 VFR1200F motorcycles because driveshaft universal joint bearings may wear prematurely, potentially causing the joint to separate or break.
Triple E RV is recalling 2014 Regency GT motorhomes because a water heater valve may cause water to overheat, potentially releasing steam and scalding the operator.
Tiny Idahomes is recalling 2014-2016 RVs equipped with specific Atwood water heaters that may overheat water, posing a scalding risk.
Mitsubishi is recalling 2014-2015 Mirage vehicles because water and salt corrosion may delay frontal air bag deployment in a crash.
K. Heeps is recalling approximately 152,010 pounds of pureed roast beef products because they may contain undeclared milk and wheat allergens.
Cost Plus World Market is recalling about 2,700 reading chairs because the front legs can bend or break, posing a fall hazard.
ShowHauler Trucks is recalling one 2013 ShowHauler motorhome because a defective water heater valve may cause water to overheat, posing a scalding risk.
Tower Cafe Inc. is recalling 1,424 tubs of Chocolate Chip Old Fashioned Gourmet Cookie Dough sold in Oklahoma due to undeclared milk, soy, and wheat allergens.
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
Green Organic Vegetables Incorporated is recalling Natures Promise Organic Edamame in Pod because the product contains undeclared soy. The recall affects 1,081 cases distributed to supermarkets in 12 states.
TN Juice Bar is recalling 137 units of the Refine 3-Day Cleanse juice kit nationwide due to unpasteurized juice with elevated pH levels and unlabeled almond milk.
Ford is recalling 2013 Explorer, Taurus, Flex, Lincoln MKS, and MKT vehicles because a cracked fuel delivery module may leak fuel and cause a fire.
North Central Industries is recalling about 2,600 Great Grizzly brand fireworks fountains because the rear plug can dislodge while lit, causing burn injuries.
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
CSM Bakery Products NA is recalling Daily Chef Peanut Butter Bars because rigid plastic pieces were found in the product.
Meijer Distribution is recalling Caramel Corn because the label lists butter but fails to declare the presence of milk, a major allergen.
Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.
Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.
Hormel Foods is recalling 153 cases of Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread due to potential metal shavings in the jars.
Tower Cafe Inc. is recalling 480 tubs of Sugar Old Fashioned Gourmet Cookie Dough in Oklahoma due to undeclared soy and wheat allergens.
NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.
Ford is recalling specific 2013 Escape and 2013-2014 Focus ST vehicles because engine wiring splices may send incorrect signals, causing hesitation or stalling.
Green Organic Vegetables is recalling Nature's Promise Organic Shelled Edamame because the product contains undeclared soy. The frozen product was distributed to supermarkets in 12 states.
Tower Cafe is recalling 656 tubs of M&M Old Fashioned Gourmet Cookie Dough sold in Oklahoma due to undeclared milk, soy, wheat, and yellow #5.
NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
NxStage Medical is recalling 2,134 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
Siemens Healthcare Diagnostics is recalling 3,601 Dimension Vista magnesium reagent cartridges due to erroneous low results that may affect patient and quality control testing.
Qualgen is recalling 4,221 vials of compounded Estradiol USP pellets nationwide because deficient practices may have impacted sterility assurance.
Felt Bicycles is recalling 645 model year 2015 mountain bikes because the carbon fiber seatposts can crack and break, posing injury and fall hazards.
Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.
NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.
Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.
Tower Cafe Inc. is recalling 596 tubs of Oatmeal Raisin Old Fashioned Gourmet Cookie Dough sold in Oklahoma due to undeclared soy and wheat allergens.
Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.
Something Special Deli-Foods Ltd. is voluntarily recalling Cranberry Chipotle Spread due to the potential for mold.
Becton, Dickinson and Company is recalling three lots of CD64 APC-R700 reagent because they are contaminated with CD4 antibody, which may cause unexpected staining patterns.
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