Archive
1,186 recalls were announced in September 2015.
Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.
Which agencies issued them
Mutual Pharmaceutical is recalling Imipramine HCl tablets because benzophenone leached from the label varnish. The recall covers 10,080 bottles distributed nationwide.
Coloma Frozen Foods is recalling IQF Red Tart Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.
Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.
Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.
Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.
Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.
Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration with elevated mold, yeast, and coliform counts.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.
Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.
Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.
Mutual Pharmaceutical is recalling 5,472 bottles of Imipramine HCl 10 mg tablets because benzophenone leached from the label varnish.
Healthpoint, Ltd is recalling 11,910 bottles of Surgicept surgical hand scrub because a naphthalene compound was identified in the product.
Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.
Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.
Bestco, Inc. is recalling CVS Sugar Free Black Cherry Cough Drops because they may contain comingled Sugar Free Honey Lemon cough drops.
Mutual Pharmaceutical is recalling specific lots of Imipramine HCl tablets because benzophenone leached from the label varnish.
Oasis Medical is recalling 909 cartons of ImproVue Ophthalmic Lubricant Drops due to a failure to meet pH specifications. The affected lot was distributed in Florida.
Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.
Golden State Medical Supply Inc. is recalling 1,165 bottles of Methocarbamol 500 mg tablets because they contain hair.
Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the product label varnish.
Honda is recalling 2014-2015 Civic and 2015 Fit vehicles to update transmission software that may damage the drive pulley shaft, potentially causing loss of acceleration or wheel lockup.
Old World Industries is recalling specific Peak Lithium Rechargeable Jump-Starters because the lithium battery may overheat, increasing the risk of fire.
Segway is recalling approximately 17 off-board chargers for its Personal Transporters because a wire can detach and cause an electric shock. No injuries have been reported.
Nissan is recalling 2007-2012 Versa vehicles sold in 23 states and D.C. because road salt may corrode front coil springs, potentially causing them to fracture and puncture tires.
McNeilus is recalling 2013-2015 concrete mixers and refuse trucks because the installed fire extinguishers may fail to discharge, increasing injury risk during a fire.
Triple E is recalling 2015-2016 Unity motorhomes because the battery compartment was not properly sealed, allowing explosive gases to enter the vehicle and increasing fire risk.
Jaguar is recalling one 2016 F-Type vehicle because the power steering system may be in factory operating mode, potentially causing loss of control.
Jaguar Land Rover is recalling 5,914 vehicles because the owner's handbook incorrectly describes the Air Bag Status Indicator Lamp, potentially increasing injury risk in a crash.
Lota USA is recalling about 4,500 Glacier Bay and Schön touchless kitchen faucets sold at The Home Depot because the battery box can short circuit, overheat, or melt, posing fire and burn risks.
Hyundai is recalling 2011-2012 Sonata vehicles because metallic debris in the engine crankshaft may restrict oil flow, potentially causing engine failure and increasing crash risk.
The Pork Rind Factory is recalling approximately 18,406 pounds of pork rinds because they contain undeclared milk and soy allergens.
Philips is recalling about 370,000 halogen bulbs because the lens can shatter, posing laceration and burn risks. Consumers should stop using them and contact Philips for a free replacement.
Cequent is recalling specific Reese Explore Bike Carriers because incorrectly molded cradles may rip and fail, causing bicycles to fall off the rack.
Juratoys is recalling Sardines and Starfish fishing games because small plastic parts can detach, posing a choking hazard to children.
Entegra is recalling 2010 Anthem and 2012-2014 Cornerstone motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase fire risk.
Mahina Mele Farm is recalling Baby Bruddah's Mac Nut Buttah because an ingredient sample tested positive for Salmonella.
Mahina Mele Farm is recalling Baby Bruddah's Chocolate Mac Nut Buttah because an ingredient sample tested positive for Salmonella.
Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.
Good Seed, Inc. is voluntarily recalling mung bean sprouts due to potential Listeria monocytogenes contamination. The products were distributed to retail stores in Virginia, Maryland, and New Jersey.
Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella.
Mahina Mele Farm is recalling salted macadamia nuts after an FDA sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Panoramic Rental Corp. is recalling 7,885 Panoramic X-ray Model PC-1000 units due to a jackscrew nut part failure that could cause device malfunction and injury.
South Coast Specialty Compounding is recalling Methyl Folate Injection vials due to potential penicillin cross-contamination. The recall covers 335 vials distributed nationwide.
Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.
Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Westbrook's Cannery is recalling 16-ounce jars of Horseradish Dill Pickles because the products may be underprocessed. Consumers in 11 states should stop using the product.
South Coast Specialty Compounding is recalling Bi-Est cream due to potential penicillin cross contamination. The recall covers 36 prescriptions distributed nationwide.
South Coast Specialty Compounding is recalling Chorionic Gonadotropin/Hydroxocobalamin Injectable vials due to potential penicillin cross-contamination.
South Coast Specialty Compounding is recalling Estradiol, Estriol, and Progesterone capsules due to potential penicillin cross-contamination.
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Customed, Inc. is recalling 84 units of Laparoscopy-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.
Chetak New York is recalling 300 jars of Deep Coriander Powder because they may be contaminated with Salmonella.
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
Westbrook's Cannery is recalling 12-ounce jars of Dilly Beans because they may be underprocessed. The product was distributed to 11 states.
Good Seed, Inc. is voluntarily recalling soybean and mung bean sprouts due to potential Listeria monocytogenes contamination.
South Coast Specialty Compounding is recalling Bi-Est 80:20 Progesterone capsules due to potential penicillin cross-contamination.
South Coast Specialty Compounding is recalling 61 prescriptions of Estriol and Estradiol cream because the products may be contaminated with penicillin.
Customed, Inc. is recalling 192 D & C Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling five prescriptions of Bi-Est hormone drops due to potential penicillin cross contamination.
Covidien is recalling 56,000 sets of Physio-Control QuikCombo electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
South Coast Specialty Compounding is recalling Meloxicam 12 mg capsules due to potential penicillin cross contamination. The recall covers all lots expiring in August 2015.
South Coast Specialty Compounding is recalling Estradiol and Estriol capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
South Coast Specialty Compounding is recalling Bi-Est and Progesterone Vaginal Suppositories due to potential penicillin cross-contamination.
Customed, Inc. is recalling 20 units of Endoveneous Custom Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling Leucovorin Calcium capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
South Coast Specialty Compounding is recalling Tri-Est 80:10:10 capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.
Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.
Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.
Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 106 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 280 Foley Catheter Kits II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 426 laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Customed, Inc. is recalling specific lots of Laparoscopy Chole 4/CS in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 546 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling specific KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the device's intended function.
Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 177 units of Shoulder Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Turbo-Cleaning Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.
Customed, Inc. is recalling specific lots of Ear Packs used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 432 Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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