CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies
Remote Diagnostic Technologies is recalling Inseego USB8 Dongle Kit, distributed nationwide in the US. The recall was initiated on 30 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2175-2025
- FDA event ID
- 97197
- Recalling firm
- Remote Diagnostic Technologies, Farnborough
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2025
- FDA classified
- 25 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 30 May 2025 | Recall initiated by company | |
| 25 Jul 2025 | Classified by FDA | +56 days |
| 6 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Where it was distributed
Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
Questions about this recall
Why was it recalled?
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Which lots are affected?
REF/UDI-DI: 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932. Software Version: vx.28
Where was it sold?
Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Remote Diagnostic Technologies
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Other | Nationwide |
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
| Device | CLASS II | Tempus Pro Patient Monitor, REFs recalled | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS III | Tempus LS-Manual Defibrillator recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Tempus LS-Manual Defibrillator recalled | Remote Diagnostic Technologies | Other | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |