Browse Device Recalls
2,805 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,805 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 2,805 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2025 | NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.... | To remove the software applications from certain CT systems as the applications have not received... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2025 | Portex Spinal Tray, Item No. A3729-24 A3595 | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| Dec 19, 2025 | Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Mo... | Due to products not having FDA Premarket authorization to be distributed within the United States. | Class II | MicroPort Orthopedics Inc. |
| Dec 19, 2025 | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number D... | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual scre... | Class II | Tornier, Inc |
| Dec 19, 2025 | Clearest Strep-A Cassette Test. Test to determine the presence of group A str... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 19, 2025 | VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P... | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or re... | Class II | ICU Medical Inc. |
| 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 | SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo... | To remove the software applications from certain CT systems as the applications have not received... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2025 | NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification sy... | To remove the software applications from certain CT systems as the applications have not received... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 19, 2025 | Alphenix INFX-8000F, interventional fluoroscopic x-ray system | It has been discovered that there is a possibility that the fixing screws of the ceiling movement... | Class II | Canon Medical System, USA, INC. |
| Dec 19, 2025 | Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist ... | The supplier manufactured anatomical left plates with an incorrect thread orientation. | Class II | Tyber Medical |
| Dec 19, 2025 | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: R... | Needle free access device intended as accessory to vascular access used in hemodialysis or access... | Class II | ICU Medical, Inc. |
| 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 19, 2025 | VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 | There is a potential for formation of ice occurring in the venting system of the superconducting ... | Class II | Canon Medical System, USA, INC. |
| Dec 18, 2025 | Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Dec 18, 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly... | Class II | Vascutek, Ltd. |
| Dec 18, 2025 | Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a g... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Dec 18, 2025 | Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered ... | Potential for fraying on the body support strap. | Class II | Community Products, LLC |
| Dec 18, 2025 | Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784... | Due to product that may contain a void in the material that separates the wire guide and cutting ... | Class II | Wilson-Cook Medical Inc. |
| Dec 17, 2025 | Genesis Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Dual Thread Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Max Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Knotless Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Hybrid Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Fixone Biocomposite Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | Genesis Push-In Suture Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 17, 2025 | AlternatiV+ Screw-In Anchor | Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture bre... | Class II | Aju Pharm Co., Ltd. |
| Dec 16, 2025 | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2.... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | 25GA Subretinal Injection Cannula VS0220.25 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Tecfen Retractable Membrane Polisher, QTPR1267-23 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical I2 Injection Kit, VS0500 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical TID Pharos Illuminated Depressor, VS0801B | XXX | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ... | Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... | Class II | Medline Industries, LP |
| Dec 16, 2025 | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 15, 2025 | Allura Xper FD20; Model Number: 722006; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.