Browse Device Recalls

905 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 905 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 905 FDA device recalls in 2026.

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DateProductReasonClassFirm
Mar 11, 2026 Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... Class II Medtronic, Inc.
Mar 11, 2026 Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - ... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Mar 11, 2026 Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)108019022... Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PU... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Mar 11, 2026 PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 ... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CAT... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOU... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)1... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 11, 2026 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device... Class II Windstone Medical Packaging, Inc.
Mar 11, 2026 MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters R... Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Class II ARROW INTERNATIONAL, LLC
Mar 10, 2026 Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US An internal component of the actuators in a certain production batch may not meet the required me... Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Mar 10, 2026 ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 1084900... During patient examinations, the system may sporadically display a major increase of the x-ray do... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2026 ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system During patient examinations, the system may sporadically display a 0 x-ray dose administered to... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2026 ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ... During patient examinations, the system may sporadically display a 0 x-ray dose administered to... Class II Siemens Medical Solutions USA, Inc
Mar 9, 2026 Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum D... Due to complaints of device breakage at the traction force gauge to handle joint. Class II Clinical Innovations, LLC
Mar 9, 2026 VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68... There is a possibility of reagent leakage from the specimen container. Class II Milestone S.R.L.
Mar 9, 2026 nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft ... Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life... Class II XTANT Medical Holdings, Inc
Mar 9, 2026 LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number... Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131 Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Numb... Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554 Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 7, 2026 Philips Spectral CT on Rails. Model Number: 728334. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... Class II PHILIPS MEDICAL SYSTEMS
Mar 6, 2026 The product is a handheld ultraviolet-C germicidal wand and contains two low-... In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at l... Class II Uvlizer c/o RAIS INTERNATIONAL LLC
Mar 6, 2026 The product is a handheld ultraviolet-C germicidal wand and contains a combin... In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at l... Class II Uvlizer c/o RAIS INTERNATIONAL LLC
Mar 6, 2026 CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical ... Software issue that renders the touch screen unresponsive. Class II Integra LifeSciences Corp. (NeuroSciences)
Mar 5, 2026 COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatibl... Class II Tornier, Inc
Mar 5, 2026 COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Vue Motion V12. Product Number: 1017979. Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 4, 2026 Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... Product labeling includes a fetal indication for use that is not cleared under its 510(k). Class II Koven Technology, Inc.

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.