Class II — Zoe Medical Incorporated
| Recalling firm | Zoe Medical, Inc |
|---|---|
| Registered facility | ZOE MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
| Product | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331 |
| Quantity | 1506 units |
| Distribution | awaiting additional details |
| Initiated | 2024-08-13 |
| Classified | 2024-09-10 |
| Recall number | Z-3099-2024 |
| 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 — Zoe Medical Incorporated (Z-3099-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95160/
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