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 |
|---|---|---|---|---|
| Feb 3, 2025 | HemosIL LMW Heparin Controls; Part Number: 0020300200; | Multiple complaints indicating lower than expected quality control (QC) results and in some insta... | Class II | Instrumentation Laboratory |
| Feb 3, 2025 | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400... | Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared... | Class II | Beckman Coulter, Inc. |
| Feb 3, 2025 | Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS i... | Potential variability in calculations from fast array scans compared to array scans when operatin... | Class II | Medimaps Group |
| Feb 3, 2025 | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital S... | Due to issues associated with data migration of patient information and results to a Cloud servic... | Class II | St. Jude Medical |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig ... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Optima MR360, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tu... | Due to the inner diameter of the suction tubing connector being smaller than the suction canister... | Class II | DeRoyal Industries Inc |
| Jan 31, 2025 | Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat... | Sterility assurance with procedure trays | Class II | American Contract Systems, Inc. |
| Jan 31, 2025 | SIGNA MR380, NMRI system, Non-US Only | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover A... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Paradigm insulin pump, REF: MMT-754 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 620G (MMT-1750) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Art... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | Paradigm REF: MMT-712 and MMT-715 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf ... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Nu... | Sterility assurance with procedure trays | Class II | American Contract Systems, Inc. |
| Jan 31, 2025 | SIGNA MR355, SIGNA MR360, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | SIGNA Creator, SIGNA Explorer, NMRI systems | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus To... | The forceps have been used in ways not covered by the design resulting in breakage of the clamps. | Class II | Aesculap Inc |
| Jan 31, 2025 | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MM... | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were foun... | Class II | Medtronic MiniMed, Inc. |
| Jan 31, 2025 | Brivo MR355, NMRI system | For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute a... | Class II | GE Healthcare (China) Co., Ltd. |
| Jan 31, 2025 | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack... | Sterility assurance with procedure trays | Class II | American Contract Systems, Inc. |
| Jan 30, 2025 | Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Phili... | Class II | Telcare, LLC |
| Jan 30, 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... | Class I | Micro Therapeutics, Inc. |
| Jan 30, 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog N... | Firm became aware of software issues related to most recent firmware update which could result in... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Jan 30, 2025 | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: P... | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wal... | Class I | Micro Therapeutics, Inc. |
| Jan 29, 2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization ... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endos... | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c s... | Class II | Pentax of America Inc |
| Jan 29, 2025 | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643... | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire rema... | Class II | Stryker Corporation |
| Jan 28, 2025 | Discovery XR656HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | Class II | GE Medical Systems, LLC |
| Jan 28, 2025 | Discovery XR656 HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | Class II | GE Medical Systems, LLC |
| Jan 28, 2025 | Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00... | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | Class II | GE Medical Systems, LLC |
| Jan 28, 2025 | Optima XR646 HD. X-Ray imaging system. | The user can continue to take the next exposure after reaching the Automatic Exposure Control (AE... | Class II | GE Medical Systems, LLC |
| Jan 27, 2025 | Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutme... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP | Tissue approximation straps (zip-ties) have broken before or during implantation so firm develope... | Class II | TAS Medical Inc |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dent... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a den... | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments ... | Class II | Hiossen Inc. |
| Jan 27, 2025 | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001... | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucos... | Class II | Dexcom, Inc. |
| Jan 27, 2025 | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators... | Class II | Merit Medical Systems, 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.