Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 12, 2026 | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... | Class I | Insulet Corporation |
| Mar 12, 2026 | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Po... | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and re... | Class II | Stryker Sustainability Solutions |
| Mar 12, 2026 | B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic ... | Customers have observed quality control values out of range at the lowest quality control level (... | Class II | Brahms GmbH |
| Mar 11, 2026 | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48... | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Class I | Intuitive Surgical, Inc. |
| 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 | Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... | Class II | Daavlin Distributing Company |
| Mar 5, 2026 | Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... | Class II | Daavlin Distributing Company |
| Mar 5, 2026 | Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disor... | Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... | Class II | Daavlin Distributing Company |
| 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 |
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.