Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2026 | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as ... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, ... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline or Centurion medical convenience kits, containing Webcol Large Alcoho... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline and Centurion medical convenience kits, containing Webcol Large Alcoh... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 16, 2026 | Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Mar 9, 2026 | nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft ... | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life... | Class II | XTANT Medical Holdings, Inc |
| Mar 5, 2026 | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatibl... | Class II | Tornier, Inc |
| Mar 5, 2026 | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 5, 2026 | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... | Products from the affected device lots were labeled with expiration dates that exceed the true sh... | Class II | Cook Incorporated |
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Koven Technology, Inc. |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
| Feb 27, 2026 | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... | Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... | Class I | Medline Industries, LP |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.