Browse Device Recalls
722 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 722 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 722 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2026 | Suture Cinch Long 1pk. Endoscopic tissue approximation device. | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Class II | Boston Scientific Corporation |
| Jul 14, 2026 | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Class II | Boston Scientific Corporation |
| Jul 9, 2026 | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Numb... | Potential for arterial sheath tip separation or partial tip separation during use. | Class I | Boston Scientific Corporation |
| Jul 9, 2026 | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material... | Potential for arterial sheath tip separation or partial tip separation during use. | Class I | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... | Class II | Boston Scientific Corporation |
| Jun 26, 2026 | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D... | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component... | Class II | Galt Medical Corporation |
| Jun 19, 2026 | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001... | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns t... | Class II | Boston Scientific Corporation |
| Jun 17, 2026 | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... | Class I | Boston Scientific Neuromodulation Corporation |
| Jun 11, 2026 | FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vas... | Boston Scientific's complaint investigations have identified that a subset of air ingress complai... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vascul... | Boston Scientific's complaint investigations have identified that a subset of air ingress complai... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vascul... | Boston Scientific's complaint investigations have identified that a subset of air ingress complai... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablat... | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutan... | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAP... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 6... | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that i... | Class II | Boston Scientific Corporation |
| Jun 11, 2026 | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculatur... | Boston Scientific's complaint investigations have identified that a subset of air ingress complai... | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 18-20mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 10-12mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 8-10mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 18-20mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 15-18mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 8-10mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 15-18mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 10-12mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 12, 2026 | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-5... | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water a... | Class II | Boston Scientific Corporation |
| May 11, 2026 | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... | There is the potential for leakage along the drug pathway from the pump through the end of the ca... | Class II | Boston Scientific Corporation |
| Apr 29, 2026 | Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x... | Reusable electrodes may not meet expected performance levels. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 29, 2026 | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 29, 2026 | Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS ST... | Reusable electrodes may not meet expected performance levels. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 22, 2026 | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... | Class II | Boston Scientific Neuromodulation Corporation |
| Mar 30, 2026 | LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATI... | For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... | Class II | Boston Scientific Corporation |
| Mar 30, 2026 | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE ... | For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM dev... | Class II | Boston Scientific Corporation |
| Mar 19, 2026 | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Feb 10, 2026 | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... | Class II | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 3, 2025 | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | 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.