Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Minimum severity
OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.
Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.
Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.
Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.
Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.
North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.
WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.
Medline Industries is recalling medical procedure kits containing neuro sponges after internal review identified higher-than-expected endotoxin levels. In-market product may be out-of-specification for endotoxin.
Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards due to risk of inaccurate pH and carbon dioxide readings that could lead to inappropriate or missed treatment of acid-base disorders.
Medline Industries is recalling medical procedure kits containing neuro sponges worldwide because testing found higher-than-expected endotoxin levels, indicating products may be out-of-specification.
Medline Industries is recalling multiple IV start and securement kits nationwide because they contain non-sterile Webcol Large Alcohol Prep Pads due to discovery of a bacterial contaminant during sterilization testing.
Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads due to discovery of non-sterile product contaminated with Paenibacillus phoenicis bacteria during sterilization testing.
Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may be out of specification. The kits were distributed worldwide.
Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.
Medline Industries is recalling 208 medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may exceed product specifications.
Medline Industries is recalling multiple medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels. The affected kits were distributed worldwide.
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.
WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.
DePuy Synthes is recalling ATTUNE Revision Hinge Femoral knee implants because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Medline Industries is recalling specific blood culture and blood draw kits containing Webcol Large Alcohol Prep Pads that were found to be non-sterile due to bacterial contamination discovered during a sterilization audit.