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
Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.
Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Stryker's GoBed II MedSurg Bed was distributed to residential customers but is intended for healthcare facility use. Home users may not understand professional-level safety instructions, creating a risk of misuse.
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
Edwards Lifesciences is recalling PediaSat Oximetry Catheter Kits due to potential internal leaks within the devices. The recall involves 218 units distributed across multiple U.S. states and internationally.
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.
Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen QC reagent due to false positive test results that could lead to incorrect diagnoses. The Class II recall affects 544 units distributed nationally and internationally.
The Prime Big Wheel Stretcher was distributed to home users, but is intended for professional healthcare facility use only. Home users may not understand the professional-only instructions, creating safety risks.
Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.
Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require surgical intervention.
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.
Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.