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.
Xstrahl Limited is recalling treatment applicators for Gulmay Medical 150 and Xstrahl 150 X-ray therapy systems. The base plate may detach from the applicator body, potentially affecting treatment positioning and delivery.
Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.
Cardinal Health is recalling SmartGown Breathable Surgical Gowns because packaging seals may not remain intact, potentially compromising the gowns' sterility. The recall affects 224,312 units distributed in the US and internationally.
Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.
Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.
Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.
Smith & Nephew is recalling 38 EVOS femur plates because the product instructions contain erroneous MRI scanning conditions. The affected units were distributed nationwide across 14 states.
Activforce 2 medical devices (145 units) are being recalled due to a manufacturing defect causing inaccurate force measurement, which may lead to incorrect treatment planning. Verify your device's serial number against the FDA recall list.
Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.
Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.
Ossur Americas is updating instructions for the Miami J Select Collar (MJS-101) and Miami J Select Collar Set (MJSR-101) to provide additional guidance on device selection and proper use nationwide.
Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.
Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.
Medline Industries is recalling the Major Vascular CDS Convenience Kit because a 250 mL saline injectable component expired in April 2020, while the overall kit's expiration date was July 31, 2021. Medical professionals should stop using affected kits immediately.
Smith & Nephew is recalling 41 units of the EVOS Condylar Medial Distal Femur Plate due to erroneous MRI scanning conditions in the instructions for use.
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.
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.
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.
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.
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.
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.
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 Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.
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.