Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 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 34,608 FDA device recalls — Class II.

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DateProductReasonClassFirm
Oct 27, 2025 Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NO... Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... Class II Medline Industries, LP
Oct 25, 2025 5008X CAREsystem +CLiC +CDX; Several software anomalies with the potential to impact patient treatment, of which one includes ... Class II Fresenius Medical Care Holdings, Inc.
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Numbe... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 MAMMOMAT Revelation; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X1... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening ... Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which... Class II GE Medical Systems, LLC
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, i... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 MAMMOMAT Fusion; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 MAMMOMAT Inspiration; There were instances where the operator table was sold together with a bus-installation kit. The ... Class II Siemens Medical Solutions USA, Inc
Oct 24, 2025 Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Numb... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 24, 2025 Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 ... As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding pot... Class II Edan Diagnostics
Oct 23, 2025 BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100; The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system fro... Class II Becton Dickinson & Co.
Oct 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of... Class II BioFire Diagnostics, LLC
Oct 22, 2025 Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 22, 2025 Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class II Olympus Corporation of the Americas
Oct 21, 2025 CareLink Clinic, REF: MMT-7350 Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... Class II Medtronic MiniMed, Inc.
Oct 20, 2025 Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe... Potential for anesthesia leakage. Class II Mindray DS USA, Inc. dba Mindray North America
Oct 20, 2025 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... Class II Medtronic Perfusion Systems
Oct 20, 2025 Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La... Potential for anesthesia leakage. Class II Mindray DS USA, Inc. dba Mindray North America
Oct 18, 2025 MONARCH Bronchoscope. Model Number: MBR-000211-B Potential that product was leak tested with equipment outside of its expected operating range, re... Class II Auris Health, Inc
Oct 17, 2025 IntelePACS - InteleConnect / TechPortal Software application that receives digital images and data to be communicated, processed, manipul... Class II INTELERAD MEDICAL SYSTEMS INCORPORATED
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC
Oct 17, 2025 Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed pos... Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... Class II TECHNO-PATH MANUFACTURING LTD.
Oct 17, 2025 Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit P... Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) in... Class II Olympus Corporation of the Americas
Oct 17, 2025 Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; The possibility for this product that is intended for demonstration purposes only to be placed in... Class II Straumann USA LLC
Oct 17, 2025 MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... A potential issue with the seal integrity of header bag packaging. Class II Mozarc Medical US LLC

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.