Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 208266
FDA device recall Z-2357-2026 · posted 2026-06-18 · Open, Classified
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- 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, potentially resulting in hypoxia or hyperoxia in the patient.
- Action taken
- Firm began notifying customers on 5/8/2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were instructed to identify affected devices by following instructions provided in the letter. Devices with affected blenders should be removed from patient use, and the customer should contact a GE HealthCare Service Representative.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTM
- Quantity affected
- 550 (367 US; 183 OUS)
- Distribution
- Pending
- Date initiated
- 2026-05-08
- Date posted
- 2026-06-18
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (K070247) | Ohmeda Medical | 2007-04-20 |