Browse Device Recalls
638 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 638 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 638 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jul 23, 2021 | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) | Potential for leaks and loosening at the patient catheter connection | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Jun 3, 2021 | VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | 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 | 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 | 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 | Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) ... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| 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 | Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f)... | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | 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 | Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | 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 | VALITUDE CRT-P pacemaker, Models: a) U125 b) U128 | Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito... | Class II | Boston Scientific Corporation |
| Apr 21, 2021 | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr... | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E... | Class II | Boston Scientific Corporation |
| Apr 15, 2021 | Colpassist Vaginal Positioning Device - Product Usage: intended for use in ge... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render t... | Class II | Boston Scientific Corporation |
| Apr 15, 2021 | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usa... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render th... | Class II | Boston Scientific Corporation |
| Apr 12, 2021 | VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of o... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Mar 26, 2021 | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont... | An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal... | Class II | Boston Scientific Corporation |
| Mar 16, 2021 | EXALT Controller - Product Usage: intended for use with a Boston Scientific e... | May have been programmed with a less than optimal brightness setting resulting in a darker than ... | Class III | Boston Scientific Corporation |
| Mar 5, 2021 | MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i... | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... | Class II | Boston Scientific Corporation |
| Mar 5, 2021 | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,... | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du... | Class II | Boston Scientific Corporation |
| Jan 19, 2021 | Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Jan 19, 2021 | Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Jan 19, 2021 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Dec 15, 2020 | ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate g... | Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that d... | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod... | Accelerated battery depletion may result in a need for device replacement earlier than expected. | Class II | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM MRI S-ICD Model A219 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Dec 2, 2020 | EMBLEM S-ICD Model A209 | Electrical overstress may lead to device malfunction. | Class I | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Dec 1, 2020 | Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS... | The rotating luer fitting at the distal end of the delivery system handle may become detached fr... | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSphere" 1.5 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿ | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IcePearl" 2.1 CX Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" 1.5 MRI 90¿ Cryoablation Needle¿ | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" i-Thaw" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSeed" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" He-Thaw Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceFORCE" 2.1 CX L 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceSphere" 1.5 Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceFORCE" 2.1 CX Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" i-Thaw" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" 1.5 Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Class II | Boston Scientific Corporation |
| Nov 18, 2020 | IceRod" Prostate Cryoablation Kit | Complaint trend regarding needle shaft gas leaks. | Class II | 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.