CLEO Patient Monitor /Tranquility VS Patient Monitor — Class II medical device recall Z-1926-2019
Ongoing recall by Infinium Medical, Inc, reported 2019-07-10, distributed nationwide. The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the
| Recall number | Z-1926-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Infinium Medical, Inc, Largo, FL, United States |
| Recall initiated | 2019-05-31 |
| Classified | 2019-07-02 |
| Reported by FDA | 2019-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 95 devices |
| UPC / GTIN / UDI-DI | 00160104500674 |
| Serial numbers | 104500407, 45000043, 45000044, 45000045, 45000057, 45000058, 45000072, 45000082, 45000083, 45000084, 45000085, 48000001, 48000002, 48000003, 8094501639, 8094501659, A15, A15104500257, A15104500320, A160104500653, A160104500674, A160104500685, A160104500701, A16054500521, A16084500604 and 71 more |
Product
CLEO Patient Monitor /Tranquility VS Patient Monitor
Reason for recall
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
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-1926-2019. 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.