Browse Device Recalls

3,435 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,435 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 3,435 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code ...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Aug 4, 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Cod...	Potential for the plunger to draw back after the air has been expelled and reintroduce air back i...	Class I	Cardinal Health
Jul 21, 2021	Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,...	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
Jul 21, 2021	Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C	Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein...	Class I	Cordis Corporation
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 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 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	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 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	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	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	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 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 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 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
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 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	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	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	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	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	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 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	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	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	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.
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 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 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 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 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 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 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, 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 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

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.