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
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
Microbiologics has recalled KWIK-STIK quality control kits due to a specific lot failing to meet resistance specifications for Gentamicin Synergy. The affected bacterial strain showed unexpected susceptibility when it should have been resistant.
Microbiologics Inc is recalling Helix Elite Molecular Standards for Inactivated Influenza A/B and Respiratory Syncytial Virus because shelf life testing failed at 24 months, potentially affecting product stability.
BioPro Titanium MPJ toe implants contain incorrect documentation falsely claiming they are MR Conditional without proper testing. Patients should not assume these implants are safe for MRI.
BioPro Titanium MPJ toe implants are being recalled due to incorrect statements in device labeling claiming MR Conditional status when MR testing was not performed on the titanium version.
Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging that may compromise sterility.
BioPro is recalling Titanium MPJ toe implants (Lot 125651) with inaccurate labeling claiming MR compatibility when the implant has not been tested for magnetic resonance safety. Patients should consult their physician before MRI.
Shimadzu Medical Systems is recalling Digital Angiography System generators due to potential excessive x-ray radiation in fluoroscopic mode. Installation issues may cause radiation dose rates to exceed safe limits.
BioPro is recalling Titanium MPJ toe implants due to false MRI safety labeling. The instructions and patient cards incorrectly state the device was tested for MRI safety, but no testing was conducted.
Microbiologics Inc is recalling KWIK-STIK quality control kits containing Enterococcus faecalis because certain lots are susceptible to Gentamicin Synergy when they should be resistant. The defect could affect laboratory testing accuracy.
K2M recalled 686 units of the Everest MI XT Inner Dilator due to a manufacturing nonconformance preventing proper fit with outer dilators during surgery. Two complaints prompted the recall.
BioPro is recalling Titanium MPJ toe implants due to false claims of MRI compatibility. The device instruction manual states it is MRI-safe despite not being tested.
Microbiologics Inc. recalls Helix Elite Inactivated Neisseria gonorrhoeae Strain GL0071 molecular standard after real-time shelf life testing failed at 24 months. The product was distributed nationwide and internationally.
Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.
K2M is recalling 686 Everest MI XT Outer Dilator units due to a manufacturing nonconformance that prevents them from fitting properly with inner dilators during surgical procedures.
Acorn Stairlifts Inc. is recalling multiple stairlift models because the seats may not have adequate strength to consistently support users during continued use, creating a fall hazard.
BioPro Titanium MPJ toe implant documentation incorrectly claims MRI safety testing that was never conducted. The implant is not proven safe for MRI use.
Stryker is recalling MEDPOR Titan OFW implants after one unit was found with an incorrectly placed barrier layer. The defect resulted from manufacturing error rather than design.
ROi CPS LLC is recalling 50 kits of Regard TOTAL HIP implants distributed in Missouri due to incorrect product identification labeling on individual kits. This mislabeling could result in the wrong implant being used in surgery.
Abbott Molecular is recalling 3063 kits of Alinity m Integrated Reaction Units due to potential detachment of reaction vessels from the unit cap during transport. No injuries have been reported.
Microbiologics Inc is recalling Helix Elite Molecular Standards for inactivated RSV A because real-time shelf life testing failed at 24 months, indicating the product may not maintain stability through its claimed expiration date.
Lacrimedics is recalling approximately 5,767 units of OPAQUE Lacrimal Plugs due to potential defects in the sterile pouch seal that could compromise product sterility. The affected devices were distributed nationwide and internationally.
BioPro Titanium MPJ toe implants are recalled because labeling incorrectly claims MRI safety without actual testing. Patients should consult their physician before undergoing MRI procedures.
Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.