ProductGuru Recalls

Official recall record

Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1

US FDA — Medical Devices · 2026-05-08 · United StatesClass I
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-05-08
Country of alert
United States
Alert level
Class I
Alert type
recall
Barcode (EAN/GTIN)
00813841020010
Brand on record
Datex-Ohmeda Inc

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

All 9 official recall notices naming Datex-Ohmeda, Inc. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.