Browse Device Recalls
905 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 905 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 905 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2... | Potential for detachment of a distal tip component of the device during use. | Class II | Olympus Corporation of the Americas |
| Mar 23, 2026 | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; | The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (... | Class II | Gentuity, LLC |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cer... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 20, 2026 | Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical di... | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5... | Class II | Centinel Spine, Inc. |
| Mar 20, 2026 | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel art... | Class II | Foundation Medicine, Inc. |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: ... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Convenience kits containing Medline Namic Angiographic Control Syringes with ... | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwin... | Class I | American Contract Systems Inc |
| Mar 19, 2026 | Medline and Centurion medical procedure kits, containing Medline Neuro Sponge... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| 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 medical procedure kits, containing Medline Neuro Sponges (102 in total) | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Centurion medical procedure kits, containing Medline Neuro Sponges, labeled a... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| 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 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 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 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 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 medical procedure kits, containing Medline Neuro Sponges (961 in tota... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| 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 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 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 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 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 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 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 | Brand Name: Leksell Vantage Arc System REF: 1053958 | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinat... | Class II | Elekta, Inc. |
| 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 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 medical procedure kits, containing Medline Neuro Sponges (4077 in tot... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Medline medical procedure kits, containing Medline Neuro Sponges (1050 in tot... | During an internal review, Medline identified higher-than-expected endotoxin levels on a represen... | Class II | Medline Industries, LP |
| Mar 19, 2026 | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... | 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 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 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 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 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 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 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 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 | 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 19, 2026 | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model ... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Mod... | Potential for the accumulation of small air bubbles in the arterial line due to adherence of bloo... | Class I | B Braun Medical Inc |
| Mar 19, 2026 | Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. | Increased rate of out-of-specification endotoxin results. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
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.