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RecallWatchMedical Device Safety
Class IOngoingZ-2358-2026

Datex-Ohmeda Inc recalls Giraffe Warmer with Integrated Resuscitation System (iRes)

Datex-Ohmeda IncWaukesha, WI, United StatesReported Jun 24, 2026 · 4 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 MaintenanceUDI
    400 affected lots
    002I08B002X08B008S10B008Y09B013S09B016A09B016R09B018P10B
    +392 more019J09B028C08B02X08B033N09B037E08B038D10B038N08B042F10B042S10B042T10B045808B045M08B047I08B047J08B054C10B054I10B054L10B054N09B054O09B054U10B055D09B055V09B057908B061K09B062C10B068W10B077M09B078509B078M09B078S09B084I10B084J10B092G08B099F08BB1405629100E08B100R08B104A09B12105790133D08B136708B136W08B141J09B142009B142W09B144J08B144N08B149Q09B163608B169D08B169G08B169H08B172308B175P08B185I08B185Q08B186208B189808B189A09B189C08B189F09B193L08B193N08B195D09B195E09B195J09B195K09B198H08B210K09B210U09B218N09B219C09B219K09B220E08B226F08B244L09B260X09B266M08B267808B280F09B281H09B285J07B295H09B295J09B295P08B310I09B338707B338E07B338K07B352Y09B355P09B7979700385B1003093B1003112B1003124B1003140B1003143B1003147B1003153B1003343B1003452B1003550B1003867B1003944B1004844B1004861B1004924B1005029B1005036B1005044B1005422B1005534B1005560B1005571B1005839B1006102B1006113B1006304B1006858B1006935B1006971B1007078B1007220B1007262B1007355B1007360B1007376B1007383B1007528B1007605B1101215B1101224B1101241B1101445B1101446B1101547B1101862B1101869B1101998B1102011B1102015B1102153B1102384B1102405B1102571B1103145B1103159B1103251B1103256B1103422B1103434B1103576B1103710B1103844B1103846B1103850B1103856B1103968B1104440B1104441B1104450B1104651B1104658B1104764B1105179B1105180B1105232B1105244B1105418B1105548B1105806B1106117B1106789B1106804B1106812B1106823B1107074B1107357B1107360B1107581B1107658B1201350B1201361B1201601B1201990B1202187B1202199B1202740B1203408B1203414B1203520B1203557B1203643B1203892B1203905B1203909B1203913B1203917B1204710B1205518B1205537B1205804B1205820B1206201B1206202B1206224B1206632B1206909B1206948B1207178B1207180B1207181B1207189B1207201B1207202B1207215B1207240B1207308B1207331B1207515B1207555B1208045B1208066B1208067B1208068B1208069B1208102B1208104B1208141B1208296B1208702B1208729B1208736B1208739B1208759B1208979B1208989B1208991B1209004B1209089B1209090B1209099B1209175B1209181B1209188B1209197B1209199B1209432B1209463B1209467B1209641B1209642B1209647B1209796B1209805B1209956B1211743B1211784B1211907B1211913B1212670B1212683B1212706B1212817B1300102B1300110B1300126B1300416B1300430B1300445B1300805B1300812B1300830B1300834B1300858B1300919B1302107B1302132B1302133B1302180B1302527B1302530B1302583B1302593B1302945B1302982B1302983B1303084B1303098B1303452B1303453B1303454B1303492B1303581B1303854B1303868B1303910B1304069B1304357B1304374B1304376B1304450B1304518B1304564B1304570B1304574B1304751B1305163B1305175B1305213B1305215B1305337B1305363B1305523B1306031B1306066B1306068B1306078B1306902B1307502B1307507B1307514B1307526B1307553B1307814B1307820B1307878B1308177B1308332B1308340B1308362B1308367B1308874B1309123B1309124B1309135B1309139B1309150B1309158B1309683B1309705B1309706B1309962B1310226B1310237B1400022B1400237B1400243B1400264B1400278B1400292B1400688B1400713B1400760B1400771B1400946B1401337B1401342B1401343B1401757B1401785B1401893B1402142B1402162B1402168B1402196B1402198B1402224B1402504B1402565B1402854B1403053B1403079B1403128B1403140B1403155B1403196B1403216B1403230B1403366B1403732B1403769B1403778B1403880B1403893B1403911B1403914B1403934B1403952B1404215B1404267B1404291

What the firm is doing

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.

DistributionShow details

Pending

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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