Browse Device Recalls

24 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 24 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 24 FDA device recalls.

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DateProductReasonClassFirm
Jun 17, 2026 INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... Class I Boston Scientific Neuromodulation Corporation
Apr 29, 2026 Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x... Reusable electrodes may not meet expected performance levels. Class II Boston Scientific Neuromodulation Corporation
Apr 29, 2026 Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 Sterile anchors my lack sterility assurance. Class II Boston Scientific Neuromodulation Corporation
Apr 29, 2026 Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS ST... Reusable electrodes may not meet expected performance levels. Class II Boston Scientific Neuromodulation Corporation
Apr 22, 2026 Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... Class II Boston Scientific Neuromodulation Corporation
Jul 8, 2025 Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Numb... Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, ... Class II Boston Scientific Neuromodulation Corporation
Jul 8, 2025 Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M36... Resistance and difficulties could occur while closing the retaining clip locking mechanism, which... Class II Boston Scientific Neuromodulation Corporation
Jun 6, 2025 Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101... As a result of a comprehensive product performance review it was determine that the device and in... Class II Boston Scientific Neuromodulation Corporation
Jul 17, 2024 WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-123... Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system che... Class II Boston Scientific Neuromodulation Corporation
Apr 18, 2024 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R... Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system chec... Class II Boston Scientific Neuromodulation Corporation
May 12, 2023 Driver Instrument, part of the Superion Indirect Decompression System, REF: 1... Pending update to indirect decompression system instructions for use informing users that excessi... Class II Boston Scientific Neuromodulation Corporation
Oct 12, 2022 Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101... Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spin... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm, 3m Cable - Product Usage: The TCN Elec... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 15 cm - Product Usage: The TCN Electrode is i... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
May 30, 2019 Nitinol Thermocouple Electrode, 5cm - Product Usage: The TCN Electrode is ind... The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect re... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation
Apr 24, 2019 Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... Class II Boston Scientific Neuromodulation Corporation

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.