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
Coloplast Manufacturing is recalling Torosa Saline-Filled Testicular Prosthesis (Size Small) due to incorrect size labeling. Nineteen units were distributed in the US and Canada.
Civco Medical Instruments is recalling VirtuTRAX Instrument Navigator devices due to a potential defect that may prevent proper tightening onto medical instruments. The device was distributed worldwide.
Medline Industries is recalling Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls due to improper storage conditions. The product was shipped at room temperature instead of the required refrigerated environment.
Datascope is recalling Cardiosave Rescue Intra-Aortic Balloon Pump devices due to possibility of fluid ingress, which could short electronic components and cause unsafe system shutdown.
Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.
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 SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.
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.
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.
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.
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 EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.
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.
Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.
Activbody is recalling the Activ5 smart fitness device due to manufacturing defects causing inaccurate force measurements, which may lead to incorrect treatment planning. The device was distributed nationwide.
Olympus TJF-Q180V duodenovideoscopes with adhesive deterioration or damage may pose infection risk due to endoscope contamination. Approximately 14,447 units are affected.
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.
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 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.
Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.
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.
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.
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.
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 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.