Giraffe OmniBed infant warmer — Class I medical device recall Z-0538-2020
Terminated recall by GE Healthcare, LLC, reported 2019-12-11. Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside pan
| Recall number | Z-0538-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2019-12-03 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2024-08-15 |
| Quantity | 23,693 units |
| Model numbers | 2074920-00X-XXXXXX, 6650-0XXX-XXX, M1050205, M1136116, M1136215, M1139253, M1145528, M1145529, M1146094, M1149051, M1149079, M1149081, M1149087, M1149108, M1161324, M1161328, M1161338, M1162796, M1206147, M1235957 |
Product
Giraffe OmniBed infant warmer
Reason for recall
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
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-0538-2020. 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.