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
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
SoClean is recalling its SoClean 2 hose and mask maintenance system to reduce potential ozone gas exposure risks. An updated user manual and replacement adapter will be provided by the manufacturer.
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.
Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.
A Baxter marketing brochure for FloSeal Hemostatic Matrix contains inaccurate content that does not match the product's official Instructions for Use and Prescribing Information.
Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.
Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.
Busse Hospital Disposables is recalling tracheostomy care kits containing Nurse Assist Sterile Normal Saline because the required sterility assurance level cannot be guaranteed. Contaminated products could cause serious infections including bloodstream, respiratory, and urinary tract infections, or sepsis.
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Busse Hospital Disposables is recalling tracheostomy care kits due to failed sterility assurance. The affected product cannot guarantee required sterility levels and poses risks of infection and sepsis.
ROi CPS LLC is recalling Regard Dressing change kits (Item 800026006) due to a defective irrigation solution component. Approximately 1,830 units distributed in Louisiana are affected.
The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.