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
Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.
Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.
Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.
Smith & Nephew recalled EVOS Medial Distal Femur Plates because the Instructions for Use contain erroneous MRI scanning data that was incorrectly incorporated from a vendor report.
Boston Scientific recalled 7 ROTAPRO rotational atherectomy system consoles due to incomplete manufacturing instructions regarding proper handling of the pneumatic kit component upon failure. Affected devices were distributed in six US states and Germany.
Medline is recalling Venous Access Pack-LF Convenience Kits because the included saline solution component expired before the kit's labeled expiration date, creating a quality and safety issue.
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.
Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.
Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.
Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.
Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.
Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.
CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.
Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.
Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.