FDA recall, , High risk
Datex-Ohmeda Giraffe and Panda Infant Resuscitation Systems
The Giraffe Stand-alone Infant Resuscitation System can deliver an oxygen concentration that does not match the intended setting.
Summary by Recall Canary from the FDA notice
What happened
Datex-Ohmeda Inc of Waukesha, Wisconsin, began a recall on May 8, 2026, for the Giraffe Warmer with Integrated Resuscitation System (iRes), the Giraffe Stand-alone Infant Resuscitation System, and the Panda Freestanding Warmer, because the blender knob shaft can loosen, affecting delivered oxygen concentration and potentially causing hypoxia or hyperoxia.
The recall was added to the FDA's Enforcement Report on June 18, 2026. Products are impacted only if service blender M1091607-R was installed during the last preventative maintenance.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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.
- UDI-DI
- 00813841020010
- 12105790
- 7979700385
Product details
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 was installed during the last Preventative Maintenance- UDI-DI
- 00813841020010
- 12105790
- 7979700385
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
- UDI-DI
- 00813841020010
- 12105790
- 7979700385
Recall details
- Company began the recall
- Sold in
Pending
- Company
- Datex-Ohmeda IncWaukesha, Wisconsin
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99036
- Recall numbers
- Z-2357-2026 to Z-2359-2026
All recalls from Datex-Ohmeda Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
