Inseego USB8 4G Dongle Kit — Class II medical device recall Z-2175-2025
Ongoing recall by Remote Diagnostic Technologies Ltd., reported 2025-08-06, distributed nationwide. Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated so
| Recall number | Z-2175-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remote Diagnostic Technologies Ltd., Farnborough, United Kingdom |
| Recall initiated | 2025-05-30 |
| Classified | 2025-07-25 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Quantity | 55 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05060472440013, 05060472441027, 05060472441058, 05060472442918, 05060472442925, 05060472442932 |
| Model numbers | 00-1007-R, 00-1024-R, 00-1026-R, 01-2298, 43-2011 |
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 Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
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Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2175-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.