Browse Device Recalls

2,817 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,817 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 2,817 FDA device recalls in 2025.

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DateProductReasonClassFirm
Oct 29, 2025 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. Class II Copan Italia
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the i... Class II Medicrea International
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 RATE FLOW set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 ADDitIV utilized in gravity IV administration sets and pump administration se... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum tr... Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. Class II Copan Italia
Oct 29, 2025 Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable ... There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of even... Class II Medtronic, Inc.
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Outlook set utilized in gravity IV administration sets and pump administratio... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Extension Set utilized in gravity IV administration sets and pump administrat... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 IV Administration Set utilized in gravity IV administration sets and pump adm... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 SAFELINE set utilized in gravity IV administration sets and pump administrati... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc
Oct 29, 2025 Anesthesia IV Set utilized in gravity IV administration sets and pump adminis... Potential for backflow of medication from secondary (piggyback) IV containers into primary IV con... Class II B Braun Medical Inc

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.