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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Sep 5, 2025 Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED... Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attac... Class II MICROVENTION INC.
May 29, 2025 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; ... Drug Elutable Microspheres have a smaller actual average diameter that is not within specificatio... Class II MICROVENTION INC.
Dec 11, 2024 MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent... Class II MICROVENTION INC.
Dec 2, 2024 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... Sterility assurance; microcatheter inner packaging may contain incomplete seal. Class II MICROVENTION INC.
Aug 5, 2024 ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years inste... Class II MICROVENTION INC.
Dec 21, 2023 TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Due to, during the manufacturing process, the prescribed manufacturing and quality processes were... Class II MICROVENTION INC.
Aug 24, 2023 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Peripheral coil system detachable has a potential of unsealed pouch packaging. Class II MICROVENTION INC.
Jun 7, 2023 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3... Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent leng... Class II MICROVENTION INC.
Sep 21, 2022 WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope... Class II MICROVENTION INC.
Oct 20, 2021 Aspiration Syringe Kit, REF: MVSK60 Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. Class II MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION 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.