Browse Device Recalls

2,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,419 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 2,419 FDA device recalls.

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DateProductReasonClassFirm
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
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 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
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 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Jan 6, 2025 NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... It was identified internally that two commingle events occurred where the metal support post with... Class II Zimmer, Inc.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 16, 2024 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... Class II Integra LifeSciences Corp.
Dec 10, 2024 Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... Class II ev3 Inc
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Dec 5, 2024 Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... Class II QUIDEL ORTHO
Nov 6, 2024 ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... Due to finished goods incorrectly packaged and labeled. Class II ICU Medical, Inc.
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography s... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed t... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tom... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/comput... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/comp... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 NOA Medical Industries Behavioral Health Hospital bed side rails, Product num... Red button used to engage side rails can break or become stuck making it difficult to engage the ... Class II NOA Medical Industries Inc
Nov 5, 2024 GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomogr... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 5, 2024 GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomogra... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Oct 25, 2024 Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: ... Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or eq... Class II Noah Medical
Oct 22, 2024 Allegedly counterfeit batteries manufactured by CSB batteries being used with... ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... Class I ICU Medical, Inc.
Sep 24, 2024 medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086 Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti... Class II Smiths Medical ASD, Inc.
Aug 20, 2024 Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 20, 2024 Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... Class I Baxter Healthcare Corporation
Aug 9, 2024 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL ... Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as ... Class II Physio-Control, 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.