Giraffe Warmer with Integrated Resuscitation System — Class I medical device recall Z-2358-2026
Ongoing recall by Datex-Ohmeda Inc, reported 2026-06-24. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an
| Recall number | Z-2358-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datex-Ohmeda Inc, Waukesha, WI, United States |
| Recall initiated | 2026-05-08 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| UPC / GTIN / UDI-DI | 00813841020010 |
Product
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Reason for recall
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
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-2358-2026. 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.