Archive
504 recalls were announced in August 2013.
Of the 504 recalls this month scored against our rubric, 4% are Critical, 25% are Severe.
Which agencies issued them
Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.
Volvo is recalling 7,767 vehicles because a software defect may cause wipers to run continuously or lights to fail, increasing crash risk.
Shoreline Fruit Inc is recalling Dark Chocolate Covered Dried Balaton Cherries because they may contain undeclared sulfites from cross-contamination with dark chocolate strawberries.
GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.
GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.
Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.
Altec is recalling 2005-2013 AH75, AH85, and AH100 aerial devices because a cable may breach insulation, increasing the risk of electrical shock to operators.
CHS Inc. is recalling IMAGIC Vegetarian Burger Mix because the soy protein isolate may be contaminated with Salmonella.
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.
Edwards Lifesciences is recalling specific lots of the EndoReturn Arterial Cannula because an incorrect component was used, which may cause performance issues with the IntraClude device.
Carestream Health is recalling DRX Evolution X-Ray systems due to a potential change in x-ray exposure technique.
GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.
Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.
Epocal is recalling 828,750 BGEM Test Cards because the glucose sensor may report low results at high concentrations after 3-4 months of storage.
Veridex is recalling CellTracks AutoPrep System software due to a reported error where patient demographics were incorrectly associated with another patient's ID.
Gasco Industrial is recalling 528 units of Golden Egg Yellow Shade Liquid in Puerto Rico due to undeclared Yellow #5 allergen.
Medtronic Navigation is correcting Framelink software version 5.4 due to potential discrepancies between exam images and displayed measurements during surgical planning.
A&M Systems is recalling electric door actuators manufactured between August 2009 and March 2010 because voltage spikes may cause circuit boards to overheat, increasing the risk of fire.
Tortillas Lupita is recalling White Corn Tortillas because flour tortillas were mislabeled as corn, containing undeclared wheat.
Showline Automotive Products is recalling REEVA Antibacterial Hand Soap and Dishwashing Liquid due to contamination with Sarcina Lutea bacteria.
Ortho-Clinical Diagnostics is recalling Colorimetric (CM)/ Rate (RT) incubator wear pads because they may become worn before their scheduled replacement.
Atrium Medical Corporation is recalling C-QUR V-Patch Mesh units because the coated mesh may adhere to the inner packaging liner when exposed to high humidity.
SpineFrontier, Inc. is recalling specific surgical case lids and bases because non-toxic inks used on the graphics are delaminating or running off after repeated washing and sterilization cycles.
Total Resources International is voluntarily recalling Medi-First 61 Piece First Aid Kits because Benzalkonium Chloride failed stability testing.
Siemens is recalling syngo.plaza software due to potential issues with mammography image laterality and alignment.
Shoreline Fruit Inc is recalling Dark Chocolate Covered Dried Balaton Cherries due to possible cross-contamination with undeclared sulfites.
Atrium Medical is recalling C-QUR Edge Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump behavior during specific alarm conditions.
Total Resources Int'l is voluntarily recalling 3M Tekk Industrial/Construction First Aid Kits due to stability testing failures of Benzalkonium Chloride.
Terumo is recalling 1,657 Advanced Perfusion System 1 units because a false high-pressure alarm can stop the pump. The company is updating manuals and issuing labeling addenda.
Medtronic Xomed is recalling 3,562 ENT surgical instrument trays to replace them with units featuring improved 'PREVACUUM ONLY' labeling.
Terumo is recalling 1,657 Advanced Perfusion System 1 units to update manuals and address a false high-pressure alarm that can stop the pump.
Ancient Formulas Inc is recalling 51,000 bulk tablets of Keytabs W.O. Glandulars because the product contains higher levels of niacin than claimed on the label.
Synthes USA is recalling 492 units of 5.0mm stainless steel spinal rods because they were produced using a finishing process not identified in the manufacturing specification.
Total Resources International is voluntarily recalling 326-piece first aid kits because the active ingredient Benzalkonium Chloride failed stability testing.
Hospira is recalling 94,110 vials of Propofol Injectable Emulsion because a single stainless steel particulate was found during inspection.
Terumo is recalling Advanced Perfusion System 1 units because user-induced movement may trigger a false 'Service Pump' error message, potentially causing unnecessary service delays.
Ancient Formulas Inc is recalling KEYTABS tablets because they contain higher levels of niacin than stated on the label.
Siemens issued a customer safety notice regarding system information overlays after brake functional checks on the AXIOM Artis zeego x-ray system.
West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because black specks of degraded organic material were found on the tablets.
Walong Marketing is recalling Asian Taste Sunflower Seeds because they may contain undeclared sulfites. The recall affects 1,090 cartons distributed in California.
Arrow International is recalling 156 Two-Lumen CVC Kits because a portion of the packaging incorrectly identifies the catheter as 3-Lumen.
Terumo is recalling 1,657 Advanced Perfusion System 1 units because user-induced motor movement can trigger a false 'Service Pump' error message, potentially misleading operators.
Terumo is recalling 1,657 Advanced Perfusion System 1 units because the operator manual does not fully describe pump reactions during specific alarm conditions.
Atrium Medical Corporation is recalling C-QUR Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
Bracco Diagnostics is recalling one lot of Gastrografin because it may contain black foreign particles.
Fisher Scientific is recalling Fisherbrand Sterile Swabs after customer complaints reported non-pathogenic organisms in two lots.
OrthoPediatrics is voluntarily recalling 68 packaged 2.5mm drill bits because the packaging incorrectly lists the size as 3.2mm.
Biomet 3i is recalling 51 dental implants because outer boxes may be mislabeled. The implants themselves are correctly labeled, but the error could prevent proper placement.
Red Mill Farms is recalling Jennies' Dutch Chocolate Macaroons because the packaging fails to list sugar as an ingredient.
Biomet 3i is recalling 33 dental implants because outer boxes may be mislabeled. The inner trays are correctly labeled, but the error could prevent proper implant placement.
Stryker is recalling 586 IsoGel AIR 84 support surfaces because connected air pumps may flash and alarm due to pressure blockages.
Atrium Medical Corporation is recalling C-QUR TacShield Mesh units because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
GE Healthcare is recalling 755 LOGIQ S8 Ultrasound Systems due to a software issue that may cause incorrect image measurements in Virtual Convex mode.
American Health Packaging is recalling bupropion hydrochloride extended-release tablets due to failed stability specifications for color, dissolution, and related compounds.
Remel Inc is recalling Flu A&B Control Swabs because they may provide incorrect negative results for Flu A, potentially compromising quality control testing.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator A lots due to under-recovery in the Total T4 assay, which may affect calibration accuracy.
Hi-Tech Pharmacal is recalling Clobetasol Propionate Cream because some cartons contain tubes with gel labels. The actual product inside is the correct cream.
Boehringer Ingelheim Roxane Inc is recalling 14,619 cartons of Prednisone 20 mg tablets because the blister cards are missing labels.
Silver Eagle is recalling 1999-2001 VAST-20W and 2001 CSL-20W trailer converter dollies because a structural defect in the axle beam can cause failure and loss of control.
Cycle Gear is recalling specific Street & Steel Big Bore motorcycle helmets that failed federal safety testing. Owners should contact the company for a replacement or reimbursement.
Crossroads RV is recalling 2012-2014 Redwood vehicles because shifting cargo may accidentally deploy the power awning while driving, increasing crash risk.
Lion Bus is recalling 2013-2014 360 school buses because emergency exit decals have letters that are too small to read, potentially hindering evacuation.
LSR Conversions is recalling four 2013 horse trailer models because a design change in the power awning motor may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.
Aluminum Trailer Company is recalling 17 model year 2013 Quest trailers because a design change in the power awning motor may cause screws to shear, risking injury or a crash.
Klever Kids is recalling about 7,000 children's pajamas and nightgowns because they fail to meet federal flammability standards, posing a burn risk.
Lion Bus is recalling 2013-2014 360 school buses because the right side mirror cannot be positioned correctly, increasing crash risk.
Apple Park is recalling about 7,250 children's two-piece loungewear sets because they fail federal flammability standards, posing a burn risk.
Wilton Industries is recalling Chefmate 2-quart tea kettles sold at Target because steam can travel up the handle or water can spill, posing a burn risk.
Kawasaki is recalling 2012-2013 Concours 14 police motorcycles because police accessories may cause the main fuse to blow, leading to engine stalling and crash risk.
TCI is recalling specific school buses with C.E. White flip seats due to a risk of foot or toe pinch injuries for rearward passengers.
Continental is recalling ATE Super Blue Racing DOT 4 Brake Fluid because its blue color fails federal safety standards, posing a risk of brake failure if mixed with incompatible fluids.
DRV is recalling 129 model year 2014 recreational vehicles and travel trailers because a design change in the power awning motor may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.
Tegol is recalling AX-3, AX-4, and TG-5 Series Outlaw motorcycle helmets because they fail to meet federal safety requirements for impact and retention.
Char-Broil is recalling about 69,300 Patio Bistro gas grills in the U.S. because the electronic ignition can unexpectedly reignite, posing a burn hazard.
Applica Consumer Products is reannouncing a recall for Black & Decker Spacemaker 12-Cup Coffeemakers because the handle can break, causing cuts and burns.
General Motors is recalling 2011-2012 Chevrolet Cruze vehicles because the electric vacuum pump may fail, reducing brake assist and increasing crash risk.
Navistar is recalling 125 model year 2013 Bison Coach recreational trailers because a design change in the power awning motor assembly may cause screws to shear, allowing the awning to unfurl unexpectedly.
JP Boden is recalling about 900 boys' and girls' sandals because the cork soles can detach, posing a trip and fall hazard to children.
Daimler is recalling 2013-2014 Thomas Built Buses Saf-T-Liner models because a fuel pickup tube label may detach and block fuel delivery, increasing crash risk.
Philips Lighting is recalling about 99,000 Endura and Ambient LED dimmable bulbs because a lead wire defect can electrify the lamp, posing a shock hazard.
IKEA is recalling KRITTER and SNIGLAR junior beds because a metal rod can break, posing a laceration hazard. No injuries have been reported.
Daimler is recalling 2013-2014 Saf-T-Liner buses because a label may fall into the fuel tank, causing the engine to stall and increasing crash risk.
Reumofan Plus tablets are being recalled because they were marketed without an approved NDA/ANDA and may contain undeclared active ingredients.
Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, making the product an unapproved new drug.
Chang Kwung Products is recalling Lightning ROD capsules because FDA analysis found an undeclared analogue of sildenafil, an unapproved new drug.
Olde Thompson, Inc. is recalling Earth's Pride Organics Organic Oregano due to a Salmonella hazard. The product was distributed to 14 states in the Northeast and Mid-Atlantic regions.
Sanofi US is recalling 2,462 bottles of Rifadin (Rifampin) 150 mg capsules because some capsules contain low fill volume, resulting in subpotent drug.
Chrysler is recalling 491 model year 2013 Fiat 500e electric vehicles because half shaft joints may loosen and separate, causing a loss of driving capability and increasing crash risk.
Hospira Inc. is recalling 1,104 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Zydus Pharmaceuticals is recalling 960 bottles of Warfarin Sodium Tablets 2 mg because a pharmacist found three oversized tablets in one bottle.
Hospira is recalling 1,976 Y-type blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Sandoz Incorporated is recalling specific lots of Methotrexate Injection vials because particulate matter was found in retention samples.
Hospira is recalling specific blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
ArjoHuntleigh is recalling Enterprise 8000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.
ArjoHuntleigh is recalling Enterprise 9000 hospital beds because the backrest or thigh sections may move without user input, posing a risk to patients in high-dependency care.
Hospira is recalling 1,152 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Superior Nut Co. Inc. is recalling raw pistachio halves after a positive laboratory test for Salmonella. The recall covers multiple bag sizes distributed nationwide and in Canada.
Apotex Corp. is recalling 52,398 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.
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