Browse Device Recalls
1,300 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,300 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 1,300 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 27, 2026 | Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESS... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DY... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline EBSI Kit EBSI1534 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: WT LAVH PACK DYNJ46609F | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ91082... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DAVINCI MAIN DYNJ908031D | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | 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 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 |
| 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 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Car... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,K... | 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 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extrav... | 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 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 |
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.