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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.