Class II — Infinium Medical, Inc
| Recalling firm | INFINIUM MEDICAL, INC. |
|---|---|
| Registered facility | INFINIUM MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. |
| Product | CLEO Patient Monitor /Tranquility VS Patient Monitor |
| Quantity | 95 devices |
| Distribution | Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin. |
| Initiated | 2019-05-31 |
| Classified | 2019-07-02 |
| Recall number | Z-1926-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Infinium Medical, Inc (Z-1926-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82999/
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