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 |
|---|---|---|---|---|
| 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 23, 2025 | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Datascope Corp. |
| Oct 23, 2025 | Cardiosave Rescue | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Class III | Datascope Corp. |
| 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 21, 2025 | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 1071123415... | Due to an device without a premarket clearance being incorrectly package and distributed. | Class III | Accriva Diagnostics, 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 |
| Oct 17, 2025 | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF... | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, wh... | Class I | CareFusion 303, Inc. |
| 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/Catalog Number: SR103B Intended for use as an unassa... | Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Oct 16, 2025 | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed... | Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly t... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Oct 16, 2025 | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. | Affected system contains components that do not meet the required distance between electrodes for... | Class II | Canon Medical System, USA, INC. |
| Oct 14, 2025 | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarb... | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactat... | Class II | Beckman Coulter Ireland, Inc. |
| Oct 14, 2025 | Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V... | Continued reports of positive cultures and infections have identified updates to the reprocessing... | Class II | Olympus Corporation of the Americas |
| Oct 14, 2025 | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; | BD has confirmed through internal testing that certain device trays failed routine biocompatibili... | Class II | Becton Dickinson & Company |
| Oct 13, 2025 | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | Class I | TMJ Solutions Inc |
| Oct 13, 2025 | DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Softwar... | Potential for device to not meet specifications resulting in incorrect results or delay of referr... | Class II | DERMASENSOR 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.