Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 26, 2025 Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007... Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR m... Class II Remote Diagnostic Technologies Ltd.
May 30, 2025 Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Dr... Kit USB flash drive contains outdated software, which could result in reverting patient monitor t... Class II Remote Diagnostic Technologies Ltd.
Apr 16, 2025 Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, wi... software issue that causes an error screen on a portable vital signs monitor when attaching video... Class II Remote Diagnostic Technologies Ltd.
Apr 15, 2025 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00... Patient Monitor software update to address issues:1)May freeze at startup with MPM Application er... Class II Remote Diagnostic Technologies Ltd.
Oct 28, 2024 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... Class III Remote Diagnostic Technologies Ltd.
May 9, 2024 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... Class II Remote Diagnostic Technologies Ltd.
Aug 24, 2023 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-... Full screen error message may occur on patient monitors with affected hardware version, either du... Class II Remote Diagnostic Technologies Ltd.
May 8, 2023 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainb... Class II Remote Diagnostic Technologies Ltd.
Feb 23, 2023 Tempus Pro Patient Monitor is a portable vital signs monitor intended to be u... During internal testing, Regulatory Compliance issues were identified regarding the Monitor and P... Class II Remote Diagnostic Technologies Ltd.
Jan 28, 2022 Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI:... Distribution of Defibrillators that are not approved or cleared for distribution US Market. Class II Remote Diagnostic Technologies Ltd.
May 25, 2021 Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. ... The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can... Class II Remote Diagnostic Technologies Ltd.
Nov 17, 2020 Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.... A software error was detected within software version 1.3.4 for the Tempus LS device. When exitin... Class II Remote Diagnostic Technologies Ltd.

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.