Browse Device Recalls

3,528 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,528 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 3,528 FDA device recalls — Class I.

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DateProductReasonClassFirm
Jul 13, 2021 EV3 Pipeline Flex Embolization Device with Flex Shield Technology Due to potential push wire fractures in the delivery system during use. The issue presents as a ... Class I Micro Therapeutics Inc,
Jul 13, 2021 Pipeline Flex Embolization Device Due to potential push wire fractures in the delivery system during use. The issue presents as a ... Class I Micro Therapeutics Inc,
Jul 7, 2021 Dose IQ Safety Software used with Spectrum IQ Infusion Pump Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose ... Class I Baxter Healthcare Corporation
Jun 18, 2021 Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.... It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... Class I Respironics California, LLC
Jun 18, 2021 Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. T... It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 a... Class I Respironics California, LLC
Jun 16, 2021 Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 7... The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalp... Class I Cardinal Health 200, LLC
Jun 14, 2021 Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Suppo... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Ser... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Conti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, R... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 14, 2021 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Venti... The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the dev... Class I Philips Respironics, Inc.
Jun 4, 2021 Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08... The patient may be exposed to potential aluminum ion release during warming therapy under certain... Class I Eight Medical International BV
Jun 4, 2021 Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 357000... System errors were noted following changes the customers implemented to the configuration of thei... Class I Baxter Healthcare Corporation
Jun 3, 2021 HeartWare HVAD Outflow Graft, REF MCS1725OG Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Accessories, REF MCS1753AK Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 HeartWare HVAD Implant Kit, REF 1104JP Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1125 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1104 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1103 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Driveline Extension Cable, REF 100 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 HeartWare HVAD Driveline Extension Cable, REF 100US Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 HeartWare HVAD Pump Implant Kit, REF 1153 Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 HeartWare HVAD Implant Kit, REF MCS1705PU Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of obser... Class I Heartware, Inc.
Jun 3, 2021 ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021) The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
Jun 3, 2021 INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f... The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P... Class I Boston Scientific Corporation
May 19, 2021 GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 Reports received of NO measured below desired dose during transition between primary console and ... Class I Vero Biotech, LLC
May 17, 2021 JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... Class I Smiths Medical ASD Inc.
May 14, 2021 DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... Class I DeRoyal Industries Inc
May 14, 2021 DeRoyal Angio Cath Removal Tray, REF 89-9936.02 DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... Class I DeRoyal Industries Inc
May 14, 2021 DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... Class I DeRoyal Industries Inc
May 7, 2021 LeadCare II Blood Lead Test Kit Catalog Number 70-6762 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 7, 2021 LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 7, 2021 LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 4, 2021 Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... The component part numbers intended for shipment to a third-party, where they are further process... Class I Medtronic Vascular
Apr 27, 2021 Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... Class I Quidel Corporation
Apr 26, 2021 Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatog... Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not author... Class I LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Apr 26, 2021 Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatogr... Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution ... Class I LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
Apr 12, 2021 VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... The firm has received reports of stent migration after implantation Class I Boston Scientific Corporation
Apr 12, 2021 VICI VENOUS STENT System Product Usage: is intended for the treatment of o... The firm has received reports of stent migration after implantation Class I Boston Scientific Corporation
Apr 9, 2021 FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part ... Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Apr 9, 2021 Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306
Apr 9, 2021 ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAK... Medical convenience kits are being recalled due to a potential breach in the package integrity of... Class I Avid Medical, Inc.
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 7T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 COVID-19 Self-Test Kit *** INNOVA *** 3T Due to distributing test kits to customers who were not part of a clinical investigation. Class I INNOVA MEDICAL GROUP, INC.
Apr 9, 2021 Kit: Midline Insertion DA. MAI Kit Part Number: 77981B Medical convenience kits are being recalled due to a potential breach in the package integrity o... Class I Medical Action Industries, Inc. 306

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.