Datex-Ohmeda Inc recalls Giraffe Warmer with Integrated Resuscitation System (iRes)
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 MaintenanceUDI400 affected lots002I08B002X08B008S10B008Y09B013S09B016A09B016R09B018P10B
+392 more
019J09B028C08B02X08B033N09B037E08B038D10B038N08B042F10B042S10B042T10B045808B045M08B047I08B047J08B054C10B054I10B054L10B054N09B054O09B054U10B055D09B055V09B057908B061K09B062C10B068W10B077M09B078509B078M09B078S09B084I10B084J10B092G08B099F08BB1405629100E08B100R08B104A09B12105790133D08B136708B136W08B141J09B142009B142W09B144J08B144N08B149Q09B163608B169D08B169G08B169H08B172308B175P08B185I08B185Q08B186208B189808B189A09B189C08B189F09B193L08B193N08B195D09B195E09B195J09B195K09B198H08B210K09B210U09B218N09B219C09B219K09B220E08B226F08B244L09B260X09B266M08B267808B280F09B281H09B285J07B295H09B295J09B295P08B310I09B338707B338E07B338K07B352Y09B355P09B7979700385B1003093B1003112B1003124B1003140B1003143B1003147B1003153B1003343B1003452B1003550B1003867B1003944B1004844B1004861B1004924B1005029B1005036B1005044B1005422B1005534B1005560B1005571B1005839B1006102B1006113B1006304B1006858B1006935B1006971B1007078B1007220B1007262B1007355B1007360B1007376B1007383B1007528B1007605B1101215B1101224B1101241B1101445B1101446B1101547B1101862B1101869B1101998B1102011B1102015B1102153B1102384B1102405B1102571B1103145B1103159B1103251B1103256B1103422B1103434B1103576B1103710B1103844B1103846B1103850B1103856B1103968B1104440B1104441B1104450B1104651B1104658B1104764B1105179B1105180B1105232B1105244B1105418B1105548B1105806B1106117B1106789B1106804B1106812B1106823B1107074B1107357B1107360B1107581B1107658B1201350B1201361B1201601B1201990B1202187B1202199B1202740B1203408B1203414B1203520B1203557B1203643B1203892B1203905B1203909B1203913B1203917B1204710B1205518B1205537B1205804B1205820B1206201B1206202B1206224B1206632B1206909B1206948B1207178B1207180B1207181B1207189B1207201B1207202B1207215B1207240B1207308B1207331B1207515B1207555B1208045B1208066B1208067B1208068B1208069B1208102B1208104B1208141B1208296B1208702B1208729B1208736B1208739B1208759B1208979B1208989B1208991B1209004B1209089B1209090B1209099B1209175B1209181B1209188B1209197B1209199B1209432B1209463B1209467B1209641B1209642B1209647B1209796B1209805B1209956B1211743B1211784B1211907B1211913B1212670B1212683B1212706B1212817B1300102B1300110B1300126B1300416B1300430B1300445B1300805B1300812B1300830B1300834B1300858B1300919B1302107B1302132B1302133B1302180B1302527B1302530B1302583B1302593B1302945B1302982B1302983B1303084B1303098B1303452B1303453B1303454B1303492B1303581B1303854B1303868B1303910B1304069B1304357B1304374B1304376B1304450B1304518B1304564B1304570B1304574B1304751B1305163B1305175B1305213B1305215B1305337B1305363B1305523B1306031B1306066B1306068B1306078B1306902B1307502B1307507B1307514B1307526B1307553B1307814B1307820B1307878B1308177B1308332B1308340B1308362B1308367B1308874B1309123B1309124B1309135B1309139B1309150B1309158B1309683B1309705B1309706B1309962B1310226B1310237B1400022B1400237B1400243B1400264B1400278B1400292B1400688B1400713B1400760B1400771B1400946B1401337B1401342B1401343B1401757B1401785B1401893B1402142B1402162B1402168B1402196B1402198B1402224B1402504B1402565B1402854B1403053B1403079B1403128B1403140B1403155B1403196B1403216B1403230B1403366B1403732B1403769B1403778B1403880B1403893B1403911B1403914B1403934B1403952B1404215B1404267B1404291
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 detailsHide
Pending
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2358-2026
- FDA 510(k) clearance · K201628The device's official FDA premarket clearance record
- FDA device classification · FMTOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5130The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Datex-Ohmeda IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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.
More Class I recalls
Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter.…
- Vascular Access Flush Saline
- Nonconforming Material/Component
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Intravascular Administration Set
- Under Investigation by firm
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
- Totally Implanted For Pain Relief Spinal-Cord Stimulator
- Device Design