Datex-ohmeda Inc: Ventilator, Emergency, Manual (resuscitator)
Summary Datex-Ohmeda is recalling certain Giraffe Stand-alone Infant Resuscitation Systems with specific service blender parts (model M1091607-R installed during recent maintenance) because the blender knob shaft can loosen, causing the device to deliver oxygen levels that don't match what the user set. This could result in patients receiving too little or too much oxygen.
- Recalling firm
- Datex-Ohmeda Inc
- Product
- 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
- 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/f56c81b7-3a00-4499-942a-d2c85f0ceeeb