Reported Jun 24, 2026 · Ongoing
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes)…
Datex-Ohmeda Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datex-Ohmeda Inc · 3114 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation
- System (iRes) Product IdentifiersM1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance
- Lot codes and dates
- UDI-DI of service blender component00813841020010 Affected devices were installed with the following serial numbers
- of affected service blender components1
002I08B002X08B008S10B008Y09B013S09B016A09B016R09B018P10B019J09B028C08B02X08B033N09B037E08B038D10B038N08B042F10B042S10B042T10B045808B045M08B047I08B047J08B054C10B054I10B054L10B054N09B054O09B054U10B055D09B055V09B057908B061K09B062C10B068W10B077M09B078509B078M09B078S09B084I10B084J10B092G08B099F08B
(2)530 of 530 codes
B1405629100E08B100R08B104A09B12105790133D08B136708B136W08B141J09B142009B142W09B144J08B144N08B149Q09B163608B169D08B169G08B169H08B172308B175P08B185I08B185Q08B186208B189808B189A09B189C08B189F09B193L08B193N08B195D09B195E09B195J09B195K09B198H08B210K09B210U09B218N09B219C09B219K09B220E08B226F08B244L09B260X09B266M08B267808B280F09B281H09B285J07B295H09B295J09B295P08B310I09B338707B338E07B338K07B352Y09B355P09B7979700385B1003093B1003112
(2)523 of 523 codes
B1505897B1505899B1505954B1505981B1505990B1505992B1505994B1505997B1506198B1506203B1506208B1506209B1506209-2B1506215B1506216B1506220B1506237B1506240B1801608B2001326B2260943BC2260311BX1101219BX1103422BX1206948BX1209647BX1302527BX1409022BX1501179BX1501323BX1501350BX1501429BX1501514BX1501668BX1501686BX1501827BX1501849BX1501857BX1501865BX1501894BX1501895BX1501897BX1501899BX1501900BX1501903BX1501911BX1502336BX1502340BX1502392BX1502444BX1502705BX1502719BX1502739BX1502748BX1502751BX1502753BX1502759BX1502764BX1502766BX1505884
1,490 of 1,490 codes
BX1901960BX1901969BX1901978BX1901981BX1901992BX1901998BX1902014BX1902036BX1902040BX1902054BX1902056BX1902066BX1902076BX1902125BX1902125-2BX1902133BX1902135BX1902137BX1902163BX1902166BX1902170BX1902193BX1902194BX1902199BX1902211BX1902235BX1902297BX1902300BX1902302BX1902367BX1902426BX1902448BX1902475BX1902557BX1902562BX1902572BX1902576BX1902579BX1902582BX1902605BX1902679BX1902692BX1902746BX1902749BX1902809BX1902828BX1902847BX1902874BX1902894BX1902907BX1902920BX1902925BX1902927BX1902933BX1902941BX1902960BX1902986BX1902989BX1903022BX1903072
- Amount recalled
- 550 (367 US; 183 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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