Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Aug 20, 2025 Model Number U226, VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S701 ALTRUA 2 SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L111, ESSENTIO DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL MRI (Model L310) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L100, ESSENTIO SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT SR SL (Model L200) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL (Model L300) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L221 PROPONENT DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U125, VALITUDE CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use i... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in ... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Aug 12, 2025 Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in... Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... Class I Max Mobility LLC
Aug 8, 2025 Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Aug 8, 2025 Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Aug 6, 2025 ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. ... Potential for undetected, deformed a-traumatic tips. Class I Olympus Corporation of the Americas
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Aug 4, 2025 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Jul 31, 2025 Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
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 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 FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; in... 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 DBL, OUS, Material Number (UPN) M635TS70020; i... 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, OUS, Material Number (UPN) M635TS70010; i... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; ... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intend... 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 DBL, US, Material Number (UPN) M635TU70020; in... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I Boston Scientific Corporation
Jul 29, 2025 WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; in... 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 ANT, US, Material Number (UPN) M635TU70040; in... 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 ANT, OUS, Material Number (UPN) M635TS70040; i... 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 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 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 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 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 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 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

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.