Browse Device Recalls

3,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,428 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 3,428 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Apr 10, 2025	CADD Solis HSPCA Pump	Pumps may experience Wireless Connection Modules intermittent connection alarms, which will inter...	Class I	Smiths Medical ASD, Inc.
Apr 10, 2025	CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO...	Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions...	Class I	Smiths Medical ASD, Inc.
Apr 10, 2025	Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/...	Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d...	Class I	Vyaire Medical
Apr 7, 2025	Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-...	A cybersecurity vulnerability was discovered through internal testing.	Class I	Baxter Healthcare Corporation
Apr 7, 2025	Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2...	A cybersecurity vulnerability was discovered through internal testing.	Class I	Baxter Healthcare Corporation
Mar 27, 2025	Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist...	In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun...	Class I	Bausch & Lomb Surgical, Inc.
Mar 27, 2025	Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env...	In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjun...	Class I	Bausch & Lomb Surgical, Inc.
Mar 21, 2025	GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 21, 2025	GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200	GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli...	Class I	GE Medical Systems China Co., Ltd.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 19, 2025	Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu...	Lack of sterility assurance for closed suction catheter systems	Class I	Avanos Medical, Inc.
Mar 13, 2025	HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775...	Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau...	Class I	Thoratec LLC
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter ...	Due to manufacturing issues there is a potential for the catheter sheath to detach.	Class I	Conavi Medical Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 12, 2025	Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ...	The potential for cracks forming in the breathing circuit hose.	Class I	Draeger, Inc.
Mar 11, 2025	BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK...	Catheters indicated for short-or-long term access to the central venous system have tubing that e...	Class I	Bard Access Systems, Inc.
Mar 4, 2025	Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P...	AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre...	Class I	ZOLL Circulation, Inc.
Feb 27, 2025	Tandem Mobi Insulin Pump with Interoperable Technology	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,...	Class I	Tandem Diabetes Care, Inc.
Feb 27, 2025	t:slim X2 Insulin Pump with Interoperable Technology	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,...	Class I	Tandem Diabetes Care, Inc.
Feb 26, 2025	Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu...	Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara...	Class I	Qapel Medical Inc.
Feb 26, 2025	Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C...	Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the oute...	Class I	Covidien
Feb 24, 2025	Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ...	Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025	Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab...	Medline medical procedure kits, containing Medtronic Aortic Root Cannula	Class I	MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025	Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab...	Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025	Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab...	Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2025	Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab...	Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p...	Class I	MEDLINE INDUSTRIES, LP - Northfield

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.