Giraffe Stand-alone Infant Resuscitation System
Medical device recall Z-2357-2026. Published in FDA’s Enforcement Report on Jun 24, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 24, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 550 (367 US; 183 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
550 (367 US; 183 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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 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…
FDA’s list runs to 25,335 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Pending
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 8, 2026.
- FDA classified it on Jun 18, 2026.
- FDA’s Enforcement Report published it on Jun 24, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datex-Ohmeda Inc, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 25,335 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.