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 |
|---|---|---|---|---|
| May 13, 2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 13, 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| Apr 24, 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... | Class II | Devicor Medical Products Inc |
| Apr 23, 2026 | Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... | 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. | Class II | SSC- Surgical Specialties Corporation |
| Apr 22, 2026 | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... | Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... | Class I | Bolton Medical Inc. |
| Apr 15, 2026 | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI ... | Due to customer complaint regarding incorrect display box labeling. | Class II | Covidien LLC |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... | Class II | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 3, 2026 | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 4... | Due to incorrect functional length on device labeling. | Class II | Grace Medical, Inc. |
| Mar 27, 2026 | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is ... | Class II | Edwards Lifesciences, LLC |
| Mar 27, 2026 | AIDBAGs are first aid kits of convenience composed of individually labeled de... | Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has b... | Class I | North American Rescue LLC. |
| Mar 25, 2026 | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number ... | Potential for mislabeled syringe produced by the i.v.STATION device. | Class I | Omnicell, Inc. |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, ... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: TAV... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: HEA... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| 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 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 | 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, 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 | 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 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 |
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.