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.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Cepheid specimen collection devices may leak after patient samples are inserted, creating risk of biohazard exposure and false positive test results. Affected devices are distributed in medical testing facilities worldwide.
Boston Scientific spinal cord stimulation implants may reset during routine charging, causing brief loss of therapy. Patients may experience undesired sensations when stimulation restarts, potentially leading to surgical intervention requests.
A software anomaly causes the BioButton remote monitoring wearable device to report skin temperature readings slightly out of specification, affecting accurate health data collection in home and healthcare settings.
EYE COMFORT CARE LLC is recalling the UNclog Eye Mask due to safety clips that may allow wires to detach, potentially causing electrical shorts and burn injuries.
Thoratec LLC is recalling 694 HeartMate 3 System Controllers because the UI membrane may lift along the housing, allowing fluid entry that could damage internal circuits and cause loss of power or pump failure.
DKK Dai-Ichi Shomei is recalling 555 Aurora 7 surgical light heads because frame welds can crack, causing the frame to sag, the housing to crack, or the light head to detach.
Merit Medical convenience kits containing plastic syringes are recalled due to leaks, breakage, and quality issues that may pose risks to patients undergoing cardiac and vascular procedures.
DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.
Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.
Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.
Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.
Medline procedure kits containing defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.
American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.
GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
GE SIGNA Explorer MR imaging systems with affected software versions may overheat implants during certain scan sequences. 2,528 units affected worldwide; no injuries reported.