Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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DateProductReasonClassFirm
May 1, 2025 The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used ... The Drill stop kit contains incorrect components. Class II Implant Direct Sybron Manufacturing LLC
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Stra... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 25, 2025 Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Cat... Sterility assurance for Ophthalmic knives. Class II Tecfen Medical
Apr 21, 2025 Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon... Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual c... Class II Capnia Inc
Apr 14, 2025 Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI cod... Due to packaging mix up. Package of finished devices were reported to have an incorrect finished... Class II Prismatik Dentalcraft, Inc.
Apr 8, 2025 REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... Due to a software issue, the software may incorrectly process the date of birth (DoB) received fr... Class II Beckman Coulter Inc.
Apr 8, 2025 Artix MT Thrombectomy Device, REF: 32-102 Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for... Class II Inari Medical - Oak Canyon
Apr 2, 2025 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... Due to manufacturing issues, abutment products were manufactured with screw seat located too high... Class II Preat Corp
Mar 20, 2025 GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... Class II Agilent Technologies, Inc.
Mar 20, 2025 Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION... Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the b... Class II Channel Medsystems, Inc.
Mar 20, 2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... Class II Beckman Coulter Inc.
Mar 17, 2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... The reason for the recall is incorrect sample barcode identification and processing errors that r... Class II Beckman Coulter Inc.
Mar 13, 2025 HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau... Class I Thoratec LLC
Mar 11, 2025 BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... Users trying to restock a single bin location of an automated dispensing cabinet, during pocket e... Class II CareFusion 303, Inc.
Mar 11, 2025 BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... Due to a software issue, when attempting to restock the automated dispensing cabinet, user have r... Class II CareFusion 303, Inc.
Mar 11, 2025 BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancie... Class II CareFusion 303, Inc.
Mar 5, 2025 HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 Due to incorrect the battery charger being packaged and distributed. Product labeling does not m... Class II Advanced Bionics, LLC
Mar 4, 2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre... Class I ZOLL Circulation, Inc.
Mar 4, 2025 InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... Insulin pens may have been incorrectly assembled therefore users could experience the following: ... Class II Medtronic MiniMed, Inc.
Feb 27, 2025 Tandem Mobi Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Feb 27, 2025 t:slim X2 Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... Class I Tandem Diabetes Care, Inc.
Feb 26, 2025 DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... Class II Beckman Coulter Inc.
Feb 26, 2025 Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu... Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara... Class I Qapel Medical Inc.
Feb 26, 2025 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped... Class II Intuitive Surgical, Inc.
Feb 24, 2025 Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... Class II PYRAMES INC
Feb 19, 2025 CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended fo... Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to ... Class I Calyxo, Inc.
Feb 18, 2025 BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 18, 2025 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Software issue that may result in outdated automated programming request(APR) being sent to the p... Class I CareFusion 303, Inc.
Feb 15, 2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... Class II Abbott Medical
Feb 6, 2025 BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... Sync timeout may occur between the server and automated dispensing device, due to a server softwa... Class II CareFusion 303, 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 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 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 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 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 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 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 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

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.