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 has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/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.
Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.
DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.
DePuy Orthopaedics is recalling 781 hip stem implants that may have an undersized spigot bore diameter, potentially preventing surgical removal without additional surgical delay or bone damage.
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.
DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.
Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.
Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.
Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.
Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.
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.
PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.
The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.
DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.
Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.
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.
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.
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.
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.
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 power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.
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.
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.
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.