Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
Jun 23, 2025 BD COR System Software. Model Number: 444829. Potential for functionality issue that supports the Over labeling feature and could lead to poss... Class II Becton Dickinson & Co.
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking... Class I Thoratec LLC
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 23, 2025 Automated Impella Controller (AIC), used in left heart support blood pump, in... A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ... Class I Abiomed, Inc.
Jun 20, 2025 GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine ... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 20, 2025 GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Certain Spectrum infusion pumps may have an incorrect version of software. Class I Baxter Healthcare Corporation
Jun 20, 2025 GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography wi... GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Certain Spectrum infusion pumps may have an incorrect version of software. Class I Baxter Healthcare Corporation
Jun 20, 2025 GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Signa Voyager, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Signa Artist, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 19, 2025 Portable X-ray system Some DIOX-602 units currently in use within the United States do not meet the minimum SSD require... Class II DIGIMED CO., LTD
Jun 18, 2025 Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladde... Class II C.R. Bard Inc
Jun 18, 2025 Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model N... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacua... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard e... Natus received two complaints of left side labeling show impedance for right side. Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Jun 18, 2025 Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/C... There is the potential that the silicone implant may contain foreign material Class II Osteotec Limited
Jun 18, 2025 Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 18, 2025 Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The E... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter access... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 17, 2025 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminu... Class II Microbiologics 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.