GEM FLOW COUPLER Monitor — Class II medical device recall Z-2208-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-07-26. An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue o
| Recall number | Z-2208-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-06-19 |
| Classified | 2023-07-20 |
| Reported by FDA | 2023-07-26 |
| Quantity | 122 units |
| UPC / GTIN / UDI-DI | 00844735006148 |
Product
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Reason for recall
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.
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-2208-2023. 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.