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
Jul 29, 2025	WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; ...	Boston Scientific has identified a higher likelihood of air embolism events when procedures are p...	Class I	Boston Scientific Corporation
Jul 29, 2025	WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; in...	Boston Scientific has identified a higher likelihood of air embolism events when procedures are p...	Class I	Boston Scientific Corporation
Jul 25, 2025	Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,...	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Jul 25, 2025	Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit...	Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai...	Class I	MEDLINE INDUSTRIES, LP - Northfield
Jul 24, 2025	ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardiover...	Affected lead models may experience gradually rising LVSI measurements in association with calcif...	Class I	Boston Scientific Corporation
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lea...	Affected lead models may experience gradually rising LVSI measurements in association with calcif...	Class I	Boston Scientific Corporation
Jul 24, 2025	ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead,...	Affected lead models may experience gradually rising LVSI measurements in association with calcif...	Class I	Boston Scientific Corporation
Jul 24, 2025	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: D...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 24, 2025	Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dex...	The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iO...	Class I	Dexcom, Inc.
Jul 21, 2025	Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF:...	Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16")...	Class I	Tandem Diabetes Care, Inc.
Jul 14, 2025	Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ...	Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.	Class I	MEDLINE INDUSTRIES, LP - Northfield
Jul 14, 2025	Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS	Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) du...	Class I	Baxter Healthcare Corporation
Jul 11, 2025	BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1...	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0...	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and ...	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-011...	Laryngoscope handles may not illuminate as intended.	Class I	Flexicare Medical (Dongguan) Ltd.
Jul 11, 2025	Plum Duo Infusion System, List Number: 400020401	ICU Medical identified two sequences of programming events and alarm interactions that may cause ...	Class I	ICU Medical, Inc.
Jul 10, 2025	Multi Joystick R-net. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-MULTI-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	All-round Joystick R-net Light. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-ARLITE-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	Micro Joystick R-net. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 10, 2025	IDM-MICRO-R. Electrical wheelchair component.	Devices with firmware versions 2.3 and lower may experience timing variations between software ta...	Class I	mo-Vis BVBA
Jul 9, 2025	Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us...	Label is incorrect. The product label indicates that the device contains an air eliminating filte...	Class I	B BRAUN MEDICAL INC
Jul 9, 2025	Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C...	Potential for the manometer port being blocked rendering the manometer non-functional.	Class I	Ambu Inc.
Jul 8, 2025	BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Jul 8, 2025	BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B...	Infusion pump module used with compatible pump infusion sets may perform outside the establishe...	Class I	CareFusion 303, Inc.
Jul 7, 2025	Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s...	Certain batches are being removed due to an increase in complaints received in which physicians e...	Class I	Boston Scientific Corporation
Jun 30, 2025	DreamStation Auto CPAP. Non-Continuous Ventilator.	Devices may possess a programming error resulting in an incorrect device configuration.	Class I	Philips Respironics, Inc.
Jun 30, 2025	DreamStation Auto. Non-Continuous Ventilator.	Devices may possess a programming error resulting in an incorrect device configuration.	Class I	Philips Respironics, Inc.
Jun 30, 2025	DreamStation Auto BiPAP. Non-Continuous Ventilator.	Devices may possess a programming error resulting in an incorrect device configuration.	Class I	Philips Respironics, Inc.
Jun 26, 2025	Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve...	Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fr...	Class I	Hamilton Medical AG
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC
Jun 23, 2025	Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/...	Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking...	Class I	Thoratec LLC
Jun 23, 2025	Automated Impella Controller (AIC), used in left heart support blood pump, in...	A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ...	Class I	Abiomed, Inc.
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Jun 20, 2025	Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX	Certain Spectrum infusion pumps may have an incorrect version of software.	Class I	Baxter Healthcare Corporation
Jun 17, 2025	i-view video laryngoscope. Model Number: 8008000. The i-view video laryng...	Potential for faulty devices as a result of depleted batteries.	Class I	Intersurgical Inc
Jun 16, 2025	HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt...	Class I	Draeger, Inc.
Jun 16, 2025	SafeStar 60A Plus Filter. Bidirectionally breathing system filter.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt...	Class I	Draeger, Inc.
Jun 16, 2025	SafeStar 55 Plus Filter. Bidirectionally breathing system filter.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt...	Class I	Draeger, Inc.
Jun 16, 2025	SafeStar 90 Plus Filter. Bidirectionally breathing system filter.	Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt...	Class I	Draeger, Inc.
Jun 3, 2025	Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021Z...	A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This...	Class I	Hamilton Medical AG
Jun 3, 2025	Bravo CF capsule delivery device, designed to place and attach a pH monitorin...	It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead ...	Class I	Given Imaging Ltd.
May 30, 2025	Servo-u MR Ventilator System. Model Number: 6888800.	Potential for inaccurate measurement of the patient circuit compliance during the patient circuit...	Class I	Maquet Critical Care AB

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.