Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 24, 2025 | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16,... | There is a potential intermittent issue on certain Omni Legend systems that can result in a strea... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Dec 24, 2025 | Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tournique... | Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... | Class II | Zimmer Surgical Inc |
| Dec 24, 2025 | Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit | A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit i... | Class II | Medline Industries, LP |
| Dec 24, 2025 | Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANG... | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... | Class II | Medline Industries, LP |
| Dec 23, 2025 | CellMek SPS Sample Preparation System, REF: C44603, with software | Sample preparation system designed to automate staining, lysing, cell washing has a software erro... | Class II | Beckman Coulter, Inc. |
| Dec 23, 2025 | Focalyx Fusion | Software device that is an accessory for image-guided interventional and diagnostic procedures in... | Class II | Focalyx Technologies, LLC. |
| Dec 22, 2025 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Liv... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Patient Information Center iX; Software Version Number: 4.5.0 | A recent software (SW) patch modifies Mobile Event Notification filter settings without providing... | Class II | Philips North America |
| Dec 22, 2025 | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON ... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 E... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medi... | BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packagi... | Class II | LSL Healthcare Inc. |
| Dec 19, 2025 | Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemol... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| Dec 19, 2025 | NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification ... | 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-8000C, 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 | Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococ... | Product not cleared by the FDA. | Class II | Altruan GmbH |
| 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 | Alphenix INFX-8000V, 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 | *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 | Alphenix INFX-8000H, 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 | 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. |
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.