Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2024 | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 8090... | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Class II | Nihon Kohden America Inc |
| Sep 18, 2024 | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusabl... | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Class II | Nihon Kohden America Inc |
| Apr 29, 2024 | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... | Due to software issue the device may give false "SpO2 Probe Failure" alarm | Class II | Nihon Kohden America Inc |
| Apr 29, 2022 | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to s... | Due to products being shipped/distributed to customers after the products expiration date had past. | Class II | Nihon Kohden America Inc |
| Jan 8, 2021 | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG ... | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. | Class II | Nihon Kohden America Inc |
| Dec 21, 2020 | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... | Medical device non-conformance to electrical safety standard (IEC 60601-1). | Class II | Nihon Kohden America Inc |
| Mar 13, 2017 | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Proble... | The Pause function on central monitors will not automatically resume when connected to a Life Sco... | Class II | Nihon Kohden America Inc |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail... | Class II | Nihon Kohden America Inc |
| Jun 3, 2014 | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201... | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may un... | Class II | Nihon Kohden America Inc |
| Jan 19, 2012 | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation),... | The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boa... | Class II | Nihon Kohden America 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.