Drug recall
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product…
FDA recall event 99036 · Class I · Datex-Ohmeda Inc
Key facts
| Event ID | 99036 |
|---|---|
| Recall numbers | Z-2357-2026, Z-2358-2026, Z-2359-2026 |
| Recalling firm | Datex-Ohmeda Inc |
| Product type | Devices |
| Products | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R…, 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…, Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 8, 2026 |
| Report date | Jun 24, 2026 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 3036470679 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: