Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System
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.
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
Lot / code information
- UDI
- of service blender component: 00813841020010 Affected devices were installed with the following
- Serial #
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…Show all
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 295P08B 310I09B 338707B 338E07B 338K07B 352Y09B 355P09B 7979700385 B1003093 B1003112 B1003124 B1003140 B1003143 B1003147 B1003153 B1003343 B1003452 B1003550 B1003867 B1003944 B1004844 B1004861 B1004924 B1005029 B1005036 B1005044 B1005422 B1005534 B1005560 B1005571 B1005839 B1006102 B1006113 B1006304 B1006858 B1006935 B1006971 B1007078 B1007220 B1007262 B1007355 B1007360 B1007376 B1007383 B1007528 B1007605 B1101215 B1101224 B1101241 B1101445 B1101446 B1101547 B1101862 B1101869 B1101998 B1102011 B1102015 B1102153 B1102384 B1102405 B1102571 B1103145 B1103159 B1103251 B1103256 B1103422 B1103434 B1103576 B1103710 B1103844 B1103846 B1103850 B1103856 B1103968 B1104440 B1104441 B1104450 B1104651 B1104658 B1104764 B1105179 B1105180 B1105232 B1105244 B1105418 B1105548 B1105806 B1106117 B1106789 B1106804 B1106812 B1106823 B1107074 B1107357 B1107360 B1107581 B1107658 B1201350 B1201361 B1201601 B1201990 B1202187 B1202199 B1202740 B1203408 B1203414 B1203520 B1203557 B1203643 B1203892 B1203905 B1203909 B1203913 B1203917 B1204710 B1205518 B1205537 B1205804 B1205820 B1206201 B1206202 B1206224 B1206632 B1206909 B1206948 B1207178 B1207180 B1207181 B1207189 B1207201 B1207202 B1207215 B1207240 B1207308 B1207331 B1207515 B1207555 B1208045 B1208066 B1208067 B1208068 B1208069 B1208102 B1208104 B1208141 B1208296 B1208702 B1208729 B1208736 B1208739 B1208759 B1208979 B1208989 B1208991 B1209004 B1209089 B1209090 B1209099 B1209175 B1209181 B1209188 B1209197 B1209199 B1209432 B1209463 B1209467 B1209641 B1209642 B1209647 B1209796 B1209805 B1209956 B1211743 B1211784 B1211907 B1211913 B1212670 B1212683 B1212706 B1212817 B1300102 B1300110 B1300126 B1300416 B1300430 B1300445 B1300805 B1300812 B1300830 B1300834 B1300858 B1300919 B1302107 B1302132 B1302133 B1302180 B1302527 B1302530 B1302583 B1302593 B1302945 B1302982 B1302983 B1303084 B1303098 B1303452 B1303453 B1303454 B1303492 B1303581 B1303854 B1303868 B1303910 B1304069 B1304357 B1304374 B1304376 B1304450 B1304518 B1304564 B1304570 B1304574 B1304751 B1305163 B1305175 B1305213 B1305215 B1305337 B1305363 B1305523 B1306031 B1306066 B1306068 B1306078 B1306902 B1307502 B1307507 B1307514 B1307526 B1307553 B1307814 B1307820 B1307878 B1308177 B1308332 B1308340 B1308362 B1308367 B1308874 B1309123 B1309124 B1309135 B1309139 B1309150 B1309158 B1309683 B1309705 B1309706 B1309962 B1310226 B1310237 B1400022 B1400237 B1400243 B1400264 B1400278 B1400292 B1400688 B1400713 B1400760 B1400771 B1400946 B1401337 B1401342 B1401343 B1401757 B1401785 B1401893 B1402142 B1402162 B1402168 B1402196 B1402198 B1402224 B1402504 B1402565 B1402854 B1403053 B1403079 B1403128 B1403140 B1403155 B1403196 B1403216 B1403230 B1403366 B1403732 B1403769 B1403778 B1403880 B1403893 B1403911 B1403914 B1403934 B1403952 B1404215 B1404267 B1404291 B1404430 B1404469 B1404473 B1404480 B1404481 B1404495 B1404723 B1404738 B1404754 B1404760 B1404786 B1404925 B1404981 B1405020 B1405134 B1405213 B1405218 B1405542 B1405544 B1405553 B1405558 B1405574 B1405576 B1405577 B1405589 B1405601 B1405608 B1405621 B1405622 B1405629 B1405630 B1405649 B1405688 B1405909 B1405923 B1405998 B1406104 B1406186 B1406190 B1406191 B1406196 B1406197 B1406432 B1406441 B1406479 B1406482 B1406506 B1406507 B1406518 B1406518-2 B1406528 B1406537 B1406599 B1407065 B1407092 B1407755 B1407776 B1407777 B1407786 B1408337 B1408379 B1408525 B1408533 B1409022 B1409048 B1409051 B1409052 B1409053 B1409324 B1409328 B1409329 B1409366 B1409509 B1409533 B1409546 B1409569 B1409588 B1409590 B1409651 B1409722 B1409731 B1409759 B1501314 B1501349 B1501652 B1501657 B1501675 B1501686 B1501687 B1501693 B1502040 B1502054 B1502157 B1502195 B1502200 B1502616 B1502655 B1502656 B1502659 B1502668 B1502675 B1502822 B1502887 B1502888 B1502892 B1502894 B1502899 B1503153 B1503178 B1503210 B1503224 B1503229 B1503240 B1503274 B1503472 B1503476 B1503500 B1503608 B1503611 B1503644 B1503665 B1503667 B1503673 B1503687 B1503698 B1504073 B1504076 B1504078 B1504339 B1504538 B1504754 B1504755 B1504761 B1504765 B1504800 B1504919 B1504951 B1504999 B1505000 B1505085 B1505090 B1505091 B1505092 B1505093 B1505096 B1505276 B1505301 B1505304 B1505527 B1505529 B1505536 B1505558 B1505570 B1505573 B1505575 B1505576 B1505624 B1505636 B1505637 B1505638 B1505655 B1505656 B1505825 B1505839 B1505840 B1505841 B1505842 B1505843 B1505854 B1505879 B1505884 B1505884 (2) B1505897 B1505899 B1505954 B1505981 B1505990 B1505992 B1505994 B1505997 B1506198 B1506203 B1506208 B1506209 B1506209-2 B1506215 B1506216 B1506220 B1506237 B1506240 B1801608 B2001326 B2260943 BC2260311 BX1101219 BX1103422 BX1206948 BX1209647 BX1302527 BX1409022 BX1501179 BX1501323 BX1501350 BX1501429 BX1501514 BX1501668 BX1501686 BX1501827 BX1501849 BX1501857 BX1501865 BX1501894 BX1501895 BX1501897 BX1501899 BX1501900 BX1501903 BX1501911 BX1502336 BX1502340 BX1502392 BX1502444 BX1502705 BX1502719 BX1502739 BX1502748 BX1502751 BX1502753 BX1502759 BX1502764 BX1502766 BX1505884 BX1601010 BX1601032 BX1601044 BX1601050 BX1601062 BX1601063 BX1601066 BX1601268 BX1601277 BX1601286 BX1601307 BX1601311 BX1601322 BX1601392 BX1601394 BX1601397 BX1601432 BX1601467 BX1601516 BX1601518 BX1601519 BX1601521 BX1601523 BX1601524 BX1601525 BX1601526 BX1601527 BX1601528 BX1601537 BX1601538 BX1601541 BX160155 …
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-2357-2026
- FDA 510(k) clearance · K070247The device's official FDA premarket clearance record
- FDA device classification · BTMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5915The 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
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a man…
- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination