Archive
473 recalls were announced in February 2014.
Of the 473 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.
Which agencies issued them
Medtronic is recalling GRAFTON DBM Flex units labeled as 2.5 cm x 10 cm that actually measure 2.5 cm x 5 cm.
Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.
Sysmex America is recalling 214 UF-1000i urine analyzers because a software patch error prevented proper database file purging, causing system performance issues.
Caraco Pharmaceutical Laboratories is recalling 7,005 bottles of Oxcarbazepine 300 mg tablets because some tablets are broken.
Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
Neuro Kinetics is recalling 148 Normative Data Template CDs for I-Portal devices because the data has not received FDA clearance through the 510(k) process.
RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.
Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.
Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because split tablets were found in stability samples.
Bio-Rad is recalling D-10 Dual Program software due to incorrect cartridge count updates when switching programs.
Bracco Diagnostics Inc is recalling VoLumen Barium Sulfate Suspension because the product failed stability testing for preservative content.
Starcraft Bus is recalling 2009-2010 All Star transit buses because voltage spikes may damage door actuators, increasing the risk of fire.
Diamond Coach is recalling 2009-2010 VIP/PT transit buses because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.
Aisin World Corp. of America is recalling specific automatic transmissions for Isuzu and Chrysler vehicles due to a loose snap ring that may cause a loss of power transfer.
PACCAR is recalling specific 2014-2015 Kenworth and Peterbilt tractor trailers because condensation in the intake manifold may freeze, causing exhaust flames and increasing the risk of fire or burn injury.
Rancho Feeding Corporation is recalling approximately 8.7 million pounds of beef products because they were processed from diseased animals without full federal inspection.
Gulf Stream Coach is recalling 2011 GT GulfTran shuttles because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.
Club Car is recalling about 1,800 Precedent I2 golf and transport vehicles because the passenger-side hip restraint can fracture, posing a fall hazard.
LEM Products is expanding a recall of 5-tray food dehydrators due to damaged wiring that poses a shock hazard. Consumers should stop using the units and contact the company for repair.
Nutriom LLC is recalling approximately 226,710 pounds of dried egg products due to possible Salmonella contamination. The products were shipped nationwide, to U.S. military installations, and to Canada.
Cummins is recalling Westport ISL G and ISX12 G engines because condensation in the intake manifold may freeze and interfere with the pressure sensor, potentially causing exhaust fires or burns.
Honda is recalling 2013 CB500 and CBR500 motorcycles because rocker arm shaft retaining bolts may loosen, causing oil leaks and potential engine stalls.
Rancho Feeding Corporation is recalling approximately 8.7 million pounds of beef products because they were processed without full federal inspection.
Heartland is recalling 2014 Sundance 2880RLT travel trailers because the Federal Certification label lists an incorrect gross vehicle weight rating, posing a crash risk.
Kawasaki is recalling approximately 10,000 off-road motorcycles because fuel can leak from the tank, posing a fire hazard. No injuries have been reported.
Marina's German Bakery is recalling assorted pastries because they may contain undeclared hazelnuts, walnuts, or almonds, posing a risk of allergic reactions.
B. Braun Medical Inc. is recalling 18,936 containers of Cefepime Hydrochloride and Dextrose Injection due to the presence of visible organic particulate matter.
Flat Creek Farm & Dairy is recalling Heavenly Blue cheese after routine testing revealed the presence of Salmonella.
Triarco Industries is recalling Multicolor Lightening Drink Granulation due to potential Chloramphenicol contamination. The product is for manufacturing use only.
Flat Creek Farm & Dairy is recalling Aztec Cheddar Cheese after routine testing revealed the presence of Salmonella. The product was distributed in Georgia and Florida.
Triarco Industries is recalling Red Lightening Drink Granulation due to potential contamination with Chloramphenicol. The product is for manufacturing use only.
Triarco Industries is recalling Activessence, a manufacturing ingredient, due to potential contamination with Chloramphenicol.
Toyota is recalling 2010-2014 Prius vehicles because a hybrid system component may fail, causing the vehicle to stall and increasing crash risk.
Teva Pharmaceuticals USA is recalling Valacyclovir Hydrochloride 1 g tablets because bottles may contain fragments of Pravastatin tablets.
Triarco Industries is recalling Green Lightening Drink Granulation that may be contaminated with Chloramphenicol. The product is for manufacturing use only.
Baxter Healthcare is recalling 49,932 vials of Nitroglycerin in Dextrose Injection because particulate matter was found in one vial.
Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.
Nissan is recalling 2012-2014 Frontier vehicles because an incorrectly installed circuit breaker may cause a wire harness to contact a metal bolt, potentially leading to an electrical short and fire.
Health & Beyond is recalling Tranquility dietary supplements because they contain unapproved prescription drugs, Doxepin and Chlorpromazine.
Apothecure, Inc. is recalling all lots of sterile compounded products within expiry due to lack of sterility assurance identified during an FDA inspection.
Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.
Fusion Pharmaceuticals is recalling Dicopanol FusePaq Kits for Oral Suspension because they contain yeast and mold levels above USP limits.
Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.
CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.
ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.
ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.
Visonic Amber SelectX kits are recalled because base stations may fail to detect emergency signals after a reboot. No injuries have been reported.
GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.
CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.
GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.
GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Three Feathers is recalling 480 trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.
Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.
Gotera, Inc is recalling Lenguita Cookies because the product contains undeclared wheat. The recall affects 217 cases distributed across nine states.
GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.
MAT Industries is recalling HDX and Powermate two-gallon air compressors because pressure switch terminals can contact the motor housing, posing a shock hazard.
Toyota is recalling specific 2012-2013 RAV4, Tacoma, and RX350 vehicles because an electrical component in the brake actuator may fail, causing safety systems to stop working.
Faria Limited LLC is recalling Dollar General Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.
R&M Trailer is recalling 185 model year 2012-2013 enclosed cargo trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.
GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.
Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.
GE Healthcare is recalling Precision 500D, MPI, and RXI X-ray systems because a locking nut on the overhead monitor suspension may loosen.
GE Healthcare is recalling 1,970 Giraffe Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.
Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.
Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.
Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.
Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.
Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.
Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.
Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.
Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.
Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol tablets because some tablets are broken.
Faria Limited LLC is recalling FAMILY wellness Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.
Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.
OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.
AGFA Corp. is recalling IMPAX RIS QDOC 5.8 software because patient reports may display the wrong patient name.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems to meet 510(k) clearance specifications.
Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.
Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.
Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen Oral Suspension due to discoloration and failure to meet appearance specifications.
Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP 60 mg because they failed a dissolution test at the 30-month stability time point.
Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.
Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.
Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.
PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of the bottles.
Greenstone LLC is recalling 22,529 bottles of Glipizide XL 5 mg tablets because a bulk lot failed a dissolution specification test.
PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.
PACK Pharmaceuticals is recalling specific lots of Timolol Maleate eye drops because stability samples showed white solid residue on the exterior of the bottles.
PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.
PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.
Forest Pharmaceuticals is recalling 156 bottles of Namenda XR 7 mg capsules because they failed stability dissolution testing. The affected product was distributed nationwide and in Puerto Rico.
Forest Pharmaceuticals is recalling Namenda XR sample packs because they failed stability dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.
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