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
Nov 28, 2023 Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 15, 2023 Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TR... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, RE... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Nov 15, 2023 MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... Class I MEDLINE INDUSTRIES, LP - Northfield
Oct 31, 2023 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Mod... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numbe... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 31, 2023 PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb... Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... Class II Heartware, Inc.
Oct 4, 2023 Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Oct 4, 2023 Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on... Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... Class II Edwards Lifesciences, LLC
Sep 27, 2023 JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, Inc.
Sep 27, 2023 JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, Inc.
Aug 17, 2023 exoplan version 3.1 Rijeka Software -A medical software, intended to support ... A software library filtering error has been discovered which occurs when users are using the Step... Class II Exocad GmbH
Aug 16, 2023 Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDH... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... Class II Abbott Medical
Aug 16, 2023 Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gal... Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Card... Class II Abbott Medical
Aug 9, 2023 FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOF... One respirator sample failed a filtration efficiency test. This respirator may not provide adequa... Class II O&M HALYARD, INC.
Aug 7, 2023 Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical... Class II Thoratec Corp.
Jul 27, 2023 PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mi... Class II Edwards Lifesciences, LLC
Jul 20, 2023 For intraventricular indications mainly used for operations within the brain ... Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a ... Class II Aesculap Implant Systems LLC
Jul 20, 2023 Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclav... Reports were received the elastomer cup material is crumbling. Class II Cosmedent, Inc.
Jul 13, 2023 Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300... Due to a manufacturing defect of a supplier provided component, there is a potential that the aud... Class II ICU Medical Inc
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensio... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Cur... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Str... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP
Jun 28, 2023 MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions... Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of th... Class I Covidien LP

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.