Device recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers…
Class I FDA enforcement event 99036. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Datex-Ohmeda Inc started this device recall on 8 May 2026. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class I. FDA event 99036 has 3 product records. The first FDA enforcement report date is 24 Jun 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Pending
Recalling firm
Datex-Ohmeda Inc, Waukesha, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2357-2026 | 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 | 550 (367 US; 183 OUS) | Class I | Ongoing | 24 Jun 2026 |
| Z-2358-2026 | 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. | 550 (367 US; 183 OUS) | Class I | Ongoing | 24 Jun 2026 |
| Z-2359-2026 | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance. | 550 (367 US; 183 OUS) | Class I | Ongoing | 24 Jun 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class I
- 12%
- Product records in this event
- 3Median of the firm: 3
- Events of the firm on the register
- 9
Other events of the firm
Official channels
- FDA enforcement report Z-2357-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99036. https://recallregister.com/fda/i/99036/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Pending
- What quantity of product is in FDA event 99036?
- The event has 3 product records. The first record gives this quantity:
550 (367 US; 183 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 12% of the 572 device events that started in 2026 are in Class I.