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
DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.
Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.
ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits due to missing rubber latex warning labels. Consumers with latex allergies face risk of allergic reaction if exposed to the unlabeled latex.
Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.
Gentherm Medical is recalling 484 Electri-Cool II cold therapy units (Model 767) distributed worldwide to provide updated labeling with revised operating instructions for Cold Therapy pads.
The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.
Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.
Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.
Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.
Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.