Archive
607 recalls were announced in May 2013.
Of the 607 recalls this month scored against our rubric, 4% are Critical, 32% are Severe.
Which agencies issued them
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Watermelon Fruit Bars because they contain undeclared FD&C Blue # 1. The product was sold in Michigan and Indiana.
Jubilant Cadista Pharmaceuticals is recalling specific lots of Pantoprazole Sodium Delayed Release Tablets because they were not manufactured in accordance with Good Manufacturing Practices.
Warner Chilcott is recalling specific lots of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the release liner may be difficult to remove.
Trophy Sas is recalling CareStream Dental CS 2100 X-ray systems due to a bent connector causing poor contact in the high-tension transformer power pin.
GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.
GE Healthcare is recalling 4,338 MRI systems because axial and coronal images from certain sagittal 3D series may display a left-to-right flip.
Discus Dental LLC is recalling 150 SL3 Soft-Tissue Lasers because the fiber optic system contains a fragile glass filament that broke near the handpiece.
Encore Medical is recalling five 3DKnee e+ Tibial Inserts because they were shipped with incorrect color-coded labels. The devices were distributed to California and Venezuela.
NxStage Medical is recalling 1,480 cases of PureFlow-B Solution due to potential mislabeling. The product is used for hemodialysis.
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Guava Fruit Bars because the product contains undeclared FD&C Red #40 and Blue #1 colors.
GE Healthcare is recalling specific MRI systems because reformatted images may display a left-to-right flip, potentially affecting diagnostic accuracy.
Paleteria Y Neveria La Rosita, LLC is recalling Pina Colada Dessert Bars because the product contains undeclared FD&C Red #40.
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Eskimo Dessert Bars because the product contains undeclared FD&C Blue # 1.
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Fruit Bars sold in Michigan and Indiana because the product contains undeclared FD&C Blue # 1.
Warner Chilcott is recalling 6,408 bottles of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.
Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.
Physicians Total Care is recalling one bottle of Percocet 10/325 mg tablets because it contained a foreign Endocet 10/25 mg tablet.
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Bubble Gum Frozen Dessert Bars because the product contains undeclared FD&C Red # 3.
Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges because the active ingredient, benzocaine, did not meet stability specifications.
Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Milk Dessert Bars sold in Michigan and Indiana due to undeclared FD&C Blue # 1.
Lion Bus is recalling one 2014 model year 360 bus because the air compressor and hydraulic brake lines may chafe, causing a hole in the brake line and increasing crash risk.
Chrysler is recalling 2005-2010 Jeep Grand Cherokee and 2006-2010 Jeep Commander vehicles because an electrical failure may cause the transfer case to shift into neutral, increasing crash risk.
Tiffin is recalling 2013 Breeze and Allegro motorhomes because an awning motor defect may cause the awning to unfurl unexpectedly, increasing injury or crash risk.
Chrysler is recalling 2013 RAM 1500 trucks because a stuck coolant valve may prevent the windshield defrosting system from working, increasing crash risk.
Heartland is recalling 2013-2014 travel and fifth-wheel trailers because awning motors may be damaged, causing the awning to unfurl unexpectedly and increasing injury or crash risk.
Chrysler is recalling 2008-2012 Jeep Wrangler right-hand drive vehicles because a broken airbag circuit may prevent the driver-side airbag from deploying in a crash.
Dutchmen is recalling 2013 Breckenridge recreational vehicles because an awning motor defect may cause the awning to unfurl unexpectedly, increasing the risk of injury or a crash.
General Motors is recalling 42,904 Buick and Chevrolet vehicles because a faulty module may cause battery loss, stalling, or a trunk fire.
BMW is recalling 2002-2003 models because the passenger air bag inflator may rupture, sending metal fragments into the cabin during a crash.
LEM Products Distribution is recalling 5-Tray Food Dehydrators because a fan failure can cause the unit to overheat and start a fire. Consumers should stop using the product and contact the company for repair.
Hillerich & Bradsby is recalling approximately 13,000 Louisville Slugger OneX Fastpitch softball bats because the barrel can separate from the handle during use, posing a risk of injury to nearby people.
KONI North America is recalling specific shock absorbers with incorrectly welded brackets that may bend and rest on the drive shaft, potentially compromising vehicle handling.
Cedarlane Natural Foods is recalling O Organics Black Bean Enchiladas because the product contains undeclared milk.
Brower Enterprises Inc. is recalling WOW Health Enterprises Dietary Supplement because it contains undeclared drug ingredients, making it an unapproved drug.
Axium Healthcare Pharmacy is recalling Cyanocobalamin (CMP) Injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Quadmix Custom Injectable vials due to lack of sterility assurance and quality control concerns.
Volvo Bus is recalling 2009-2013 9700 coaches because a software defect may fix the throttle at 1750 RPMs, preventing drivers from controlling speed.
Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling all lots of Cyclosporin in Corn Oil Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling BiMix Customs Injectable due to lack of sterility assurance and quality control concerns.
La Espanola Meats Inc is recalling Cabrales Rojo Prieto Cheese contaminated with Staphylococcus Aureus, E. Coli, and Alkaline Phosphatase.
Axium Healthcare Pharmacy is recalling Triamcinolone Acetonide Injectable due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling 172 vials of Triamcinolone Diacetate Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Methylcobalamin and Folic Acid Injectables because the products may lack sterility assurance.
Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling all lots of Progesterone in Olive Oil Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling QuadMix Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling BiMix Plus Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.
Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate Injectable due to lack of sterility assurance and quality control concerns.
Wild Blue Yonder Foods is recalling Chappaqua Crunch GF Simply Granola with Flax & Fruit due to undeclared almonds. The product was distributed in nine states.
Axium Healthcare Pharmacy is recalling Trimix injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling TriMix Injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate for Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Mono-mix (Prostaglandin) Injectable due to lack of assurance of sterility and quality control concerns.
Axium Healthcare Pharmacy is recalling Phosphatidylcholine Injectable due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling 17 Alpha Hydroxyprogesterone Caproate Injectable vials due to lack of sterility assurance and quality control concerns.
Axium Healthcare Pharmacy is recalling Comprehensive Injection #4 because the compounding process lacked assurance of sterility. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.
Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.
Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.
All One, Inc. is recalling 796 units of Active Senior Multiple Vitamin & Mineral Powder because the label incorrectly claims 'No Dairy' and 'Certified Vegan' despite containing whey protein isolate.
Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.
Sandoz is recalling specific lots of Amoxicillin Capsules USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
SIB, Inc. is recalling specific lots of Bakehouse Granola because the packaging fails to list milk as an ingredient, posing a risk to consumers with milk allergies.
Planet Food is recalling Yum Nature Tahini because it has the potential to be contaminated with Salmonella.
Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.
Meijer Distribution is recalling 1,080 units of Essential M with Real Strawberries because the label fails to identify soy lecithin, a potential allergen.
GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.
Triumph is recalling 2012-2013 Explorer and Explorer XC motorcycles because incorrect Gross Vehicle Weight Rating labels may lead to overloading and increased crash risk.
Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.
All One, Inc. is recalling multiple vitamin powder canisters because the label incorrectly claims 'No Dairy' and 'Certified Vegan' despite containing milk.
Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.
Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.
Newmar is recalling 2013-2014 motorhomes because an awning motor may be damaged during installation, causing the awning to unfurl unexpectedly and increasing injury or crash risk.
Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.
Newmar is recalling 2012-2013 Canyon Star motorhomes because missing rear reflectors may reduce visibility and increase crash risk.
Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.
Ozone Confection & Bakers Supply Co. is recalling 481 units of Easter Mix Non-Pareil Seeds because they contain undeclared FD&C colors.
Stellate Systems is recalling Harmonie software versions 5.1 to 6.2e because the product's labeling indications have not been cleared by the FDA for sale in the USA.
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state they retain 100% strength at six weeks, when they actually retain approximately 80%.
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state that 100% suture strength remains at six weeks.
Varian is recalling RPM Respiratory Gating System v1.7.5 units because they may produce inverted respiratory waveforms during specific sessions.
OPMX, LLC is recalling Pentrexcilina Jarabe NF liquid because its label may be confused with Pentrexyl, a prescription antibiotic.
Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative results.
OPMX, LLC is recalling Pentrexcilina tablets because the labels are misleading and may be confused with a prescription antibiotic.
Qualitest Pharmaceuticals is recalling 10,373 bottles of Glimepiride 2 mg tablets because one oversized tablet was found in a sealed bottle at the retail level.
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
Wira Corp. is recalling Jasmine Garlic Flavored Crackers due to undeclared and unapproved food color ingredients.
Royal Foods, Inc. is recalling Pantai Thai Tea because a state audit found insanitary conditions, including a leaking roof and rodent activity, at the facility.
Ozone Confection & Bakers Supply Co. is recalling 481 boxes of Non-Pareil Seeds because they contain undeclared FD&C colors.
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
Ozone Confection & Bakers Supply Co. is recalling 481 units of Non-Pareil Seeds because they contain undeclared FD&C colors.
Teleflex Medical is recalling 190,103 sterile Belly Bag Urine Collection Bags with Hip Belts because the sterile packaging may be compromised.
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