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
Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.
Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.
Cook Biotech is recalling 130 units of Biodesign Fistula Plug C-FPS-0.7-2 surgical implants because the devices expire prior to the expiration date printed on the labeling. Devices were distributed worldwide including the US and 11 other countries.
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment. The recall affects 39 units distributed worldwide.
504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.
Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.
Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.
American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.
Philips is recalling the Ingenia Elition X MRI device due to loose screws in the RF carrier assembly that could block the tabletop and delay diagnosis or cause patient anxiety.
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.
Cook Biotech is recalling Biodesign Fistula Plug C-FPS-0.2-2 implants because affected units expire before their labeled expiration dates. The defect could compromise product performance.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The recall affects 231 units distributed worldwide.
Arrow International recalls over 14,000 arterial kits due to reports of open packaging seals. The recall affects multiple models distributed nationwide.