Browse Device Recalls

5,540 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,540 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 5,540 FDA device recalls.

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DateProductReasonClassFirm
Nov 6, 2025 BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit R... Labeling discrepancy; Ureteral stent actual size may not match the actual product label. Class II C.R. Bard Inc
Nov 3, 2025 Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion Sys... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PT... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti ... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Nov 3, 2025 Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System M... Labeling contains claims that are not consistently present. Class III Orthofix U.S. LLC
Oct 31, 2025 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-10; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched... Class II Inpeco S.A.
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-40; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatche... Class II Inpeco S.A.
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 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 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 B.BRAUN 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 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 SafeDAY 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 Blood Administration Set utilized in gravity IV administration sets and pump ... 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 Burette 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 CARESAFE utilized in gravity IV administration sets and pump administration s... 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 ULTRASITE 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 Caresite utilized in gravity IV administration sets and pump administration s... 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 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 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

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.