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
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.