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 the agency’s own highest classification or reported deaths or serious injuries, 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
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
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.
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 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 its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
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.
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.
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.
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.
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.
The Prime TC-transport chair, designed for healthcare facility use, was distributed to residential customers who may not understand the professional-level operating instructions. The recall addresses potential risk of improper use by home users.
Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.
An Isolibrium Support Surface intended for healthcare facilities was distributed to home customers. While the labeling is correct, home users may not understand instructions intended for healthcare professionals.
The FDA is recalling Kaluza C Flow Cytometry Software versions 1.0, 1.1.1, and 1.1.2 due to software anomalies that may generate erroneous results affecting diagnostic interpretation.
Medline Industries is recalling Total Knee convenience kits that may contain an expired saline irrigation solution component. The expired component may not maintain proper sterility for surgical use.
Stryker's InTouch 2131 medical device, intended for healthcare facilities, was distributed to residential customers. Home users may not understand healthcare-specific instructions, creating a risk of improper use.
Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
The AMIA Sharesource User Guide for the AMIA Automated Peritoneal Dialysis System incorrectly describes the Ultrafiltration Limit setting, potentially causing patients to misunderstand when therapy should end. Approximately 5,101 affected units have been distributed worldwide.
Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.
Stryker GmbH is recalling 242 Nail Insertion Sleeves (Catalog Number 18061406S, Lot K03CC4F) because the inner diameter does not match the dimension specified on the outer box label.
Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.
All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.
Straumann USA LLC is recalling 130 units of the Straumann SCS Screwdriver (Article 046.401) due to an incorrect tip configuration that prevents proper engagement with screw heads during dental surgery, creating a potential injury risk.
Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.