Browse Device Recalls
610 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 610 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 610 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 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 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 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 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 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 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 | 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 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 25, 2025 | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 | The potentially impacted units were manufactured using specific equipment that may have caused cr... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VX... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect i... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needl... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The nee... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The need... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Mar 24, 2025 | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The ne... | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and Fe... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M0... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M0... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: ... | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 20, 2024 | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 | Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... | Class II | Boston Scientific Corporation |
| Dec 12, 2024 | ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL ... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209),... | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Dec 12, 2024 | VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) | A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 201... | Class I | Boston Scientific Corporation |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 28, 2024 | AMS Artificial Urinary Sphincter Control Pump | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... | Class II | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRB... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific 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.