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.

Clear
DateProductReasonClassFirm
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
Jun 28, 2023 Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I... Product labeling contains incorrect expiration date Class II Medtronic Neurosurgery
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 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, 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, 20 cm, Curved Extension... 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 27, 2023 Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 hole... Thread form issue of the locking holes in that the locking screws would not properly mate with th... Class II Zimmer, Inc.
Jun 20, 2023 Ringed DxI Reaction Vessels (RVs) Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immuno... Class II Beckman Coulter, Inc.
May 26, 2023 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 There was one complaint that the sidearm of the device detached during explant of a pump. When t... Class II Abiomed, Inc.
May 24, 2023 Power-PRO 2- A powered ambulance cot that consists of a platform, including a... Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... Class II Stryker Medical Division of Stryker Corporation
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G5657... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 22, 2023 Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G210... There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, wh... Class II Wilson-Cook Medical Inc.
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 18, 2023 Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at th... Class II MEDLINE INDUSTRIES, LP - Northfield
May 16, 2023 HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech,... Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monito... Class II Heartware, Inc.
May 15, 2023 Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 30, 2023 Medicine Dropper, Product Code K508 Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. Class II Apothecary Products, LLC
Mar 30, 2023 Eye and Ear Dropper, Product Code 67082 Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb. Class II Apothecary Products, LLC
Mar 22, 2023 Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusi... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000594 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 ASM Replacement Battery, Component Number SUB0000864 Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
Mar 22, 2023 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

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.