Datex-ohmeda Inc: Warmer, Infant Radiant
Datex-Ohmeda is recalling Giraffe and Panda infant warmers that have a specific service blender installed, because the blender knob shaft can loosen and cause the warmer to deliver incorrect oxygen levels to patients. This could result in either too little oxygen (hypoxia) or too much oxygen (hyperoxia) being delivered. The recall affects only warmers that received this particular blender during recent maintenance.
- Recalling firm
- Datex-Ohmeda Inc
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-08
- Status
- Open, Classified
- Distribution
- Pending
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2a174a37-59d6-4047-884d-0c548aea746b