Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
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.
Aug 2, 2024 Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Cata... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Mode... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Aug 2, 2024 Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Re... Due to a manufacturing issue, red particulates present in the expressed composite. Class II Ultradent Products, Inc.
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 25, 2024 HeartMate 3 System Controllers provided within the following HeartMate 3 Left... Left ventricular assist system controller UI membrane/screen may lift along the edge of the contr... Class II Thoratec LLC
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
May 31, 2024 Soltive Pro SuperPulsed Laser System, Model TFL-SLS Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external def... G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the scr... Class II Zoll Medical Corporation
May 31, 2024 Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 31, 2024 Soltive Premium SuperPulsed Laser System, Model TFL-PLS Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the ... Class II Olympus Corporation of the Americas
May 10, 2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue appro... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 10, 2024 PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general s... Issue on a specific packaging machine resulted in a hole in the primary packaging, product steril... Class II Ethicon, Inc.
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... Class I Thoratec Corp.
May 7, 2024 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Plum 360/A+ spare batteries. Item Number: SUB0000864. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Apr 24, 2024 Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)... The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... Class II Lucid Diagnostics, Inc.
Apr 24, 2024 Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)... The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... Class II Lucid Diagnostics, Inc.
Apr 17, 2024 Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used duri... Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may com... Class II Integra LifeSciences Corp.
Apr 11, 2024 Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that ut... The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting caus... Class II Securitas Healthcare LLC
Apr 9, 2024 The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... Class II Sophysa S.A.
Apr 9, 2024 The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... Class II Sophysa S.A.

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.