Remote Diagnostic Technologies Ltd. recalls Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an…
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead…
Read the official notice →- Date
- 2025-08-06
- Country
- United States
- Brand
- Remote Diagnostic Technologies
- Product
- Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Remote Diagnostic Technologies recalls
- 2026-01-14
USRemote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP…
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated…
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AZ, VA, FL,…Official notice →- 2025-05-14
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May…
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AZ, VA, FL,…Official notice → - 2025-04-30
- US
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007…
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
FDA · DeviceRemote Diagnostic Technologies Ltd.Worldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2024-12-04
- US
Remote Diagnostic Technologies Ltd. recalls Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or…
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
FDA · DeviceRemote Diagnostic Technologies Ltd.U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.Official notice → - 2024-06-12
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may…
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL,…Official notice → - 2023-09-27
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With…
Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required.…
FDA · DeviceRemote Diagnostic Technologies Ltd.US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME,…Official notice →
Other drugs & medical recalls in the United States
- 2025-08-06
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper…
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia,…Official notice → - US
MICROVENTION INC. recalls LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional…
FDA · DeviceMICROVENTION INC.OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France,…Official notice → - US
Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring…
FDA · DeviceSteris CorporationWorldwide - US Nationwide and Puerto Rico and the country of Canada.Official notice → - US
HeartSine Technologies Ltd recalls HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
FDA · DeviceHeartSine Technologies LtdWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop…
The Drill stop kit contains incorrect components.
FDA · DeviceImplant Direct Sybron Manufacturing LLCWorldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ,…Official notice → - US
Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice →