Datex-Ohmeda Inc medical device recall: Giraffe Stand-alone Infant Resuscitation System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99036
- Recall initiated
- May 8, 2026
- Classified by FDA
- Jun 18, 2026
- Posted in Enforcement Report
- Jun 24, 2026
- Recalling firm
- Datex-Ohmeda Inc
- Firm location
- Waukesha, WI, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 8, 2026. FDA classified it 41 days later, on Jun 18, 2026. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: Pending Datex-Ohmeda Inc has 9 recalls in our records.
Recalled products (3)
Z-2357-2026 Class I Ongoing
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
Codes / lots: UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B…
Quantity: 550 (367 US; 183 OUS)
Z-2358-2026 Class I Ongoing
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.
Codes / lots: UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B…
Quantity: 550 (367 US; 183 OUS)
Z-2359-2026 Class I Ongoing
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Codes / lots: UDI-DI of service blender component: 00813841020010 Affected devices were installed with the following serial numbers of affected service blender components: 002I08B 002X08B 008S10B 008Y09B 013S09B 016A09B 016R09B 018P10B 019J09B 028C08B 02X08B 033N09B 037E08B 038D10B 038N08B 042F10B 042S10B 042T10B 045808B 045M08B 047I08B 047J08B 054C10B 054I10B 054L10B 054N09B 054O09B 054U10B 055D09B 055V09B 057908B 061K09B 062C10B 068W10B 077M09B 078509B 078M09B 078S09B 084I10B 084J10B 092G08B 099F08B 1 B1405629 100E08B 100R08B 104A09B 12105790 133D08B 136708B 136W08B 141J09B 142009B 142W09B 144J08B 144N08B 149Q09B 163608B 169D08B 169G08B 169H08B 172308B 175P08B 185I08B 185Q08B 186208B 189808B 189A09B 189C08B 189F09B 193L08B 193N08B 195D09B 195E09B 195J09B 195K09B 198H08B 210K09B 210U09B 218N09B 219C09B 219K09B 220E08B 226F08B 244L09B 260X09B 266M08B 267808B 280F09B 281H09B 285J07B 295H09B 295J09B…
Quantity: 550 (367 US; 183 OUS)
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99036
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.