Browse Device Recalls

1,303 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,303 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 1,303 FDA device recalls.

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DateProductReasonClassFirm
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 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 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 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

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.