Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Medical device recall Z-2475-2026. Published in FDA’s Enforcement Report on Jun 24, 2026.
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 II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 19587 units 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
19587 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391…
Every code shown here, 1,996 characters
Serial Numbers: HDGP50034 HDGP51018 HDGS50069 HDGS50070 HDGS50074 HDGS50077 HDGS50158 HDGS50162 HDGS52245 HDGS52286 HDGT50374 HDGT50399 HDGS50464 HDGS50560 HDGS50569 HDGS50570 HDGD50349 HDGG54079 HDGJ50278 HDGJ50281 HDGJ50390 HDGJ50391 HDGJ50394 HDGJ50400 HDGK52363 HDGM50481 HDGM50482 HDGM50483 HDGM50484 HDGM50485 HDGM50486 HDGQ50625 HDGQ50626 HDGQ50627 HDGQ50628 HDGQ50629 HDGS50369 HDGS50370 HDGS50371 HDGS50372 HDGR50086 HDGL51597 HDGG54268 HDGG54270 HDGG54410 HDGK51696 HDGL51002 HDGL51003 HDGL51004 HDGL51005 HDGL51032 HDGN50383 HDGP50522 HDGQ50763 HDGQ50882 HDGQ50884 HDGQ50886 HDGQ50887 HDGQ50901 HDGQ50902 HDGQ50903 HDGQ50904 HDGQ50905 HDGQ50906 HDGQ50907 HDGQ50908 HDGQ50909 HDGQ50910 HDGQ50911 HDGQ50912 HDGQ50913 HDGQ50917 HDGS51833 HDGU60609 HDGU60732 HDGE50297 HDGE50370 HDGE50371 HDGK51791 HDGK51792 HDGK51793 HDGK51794 HDGK51795 HDGK51804 HDGK51822 HDGK51840 HDGR50087 HDGR50088 HDGR50178 HDGR50180 HDGR50184 HDGR50185 HDGN50863 HDGN50864 HDGN50865 HDGN50866 HDGN50868 HDGN50869 HDGN50870 HDGH60335 HDGH60316 HDGH60319 HDGH60320 HDGH60321 HDGH60322 HDGH60323 HDGH60324 HDGH60326 HDGH60327 HDGH60328 HDGH60329 HDGH60330 HDGH60331 HDGH60333 HDGH60334 HDGH60403 HDGH60407 HDGH60408 HDGH60409 HDGN50867 HDGT50420 HDGK51412 HDGK51706 HDGK52164 HDGL50039 HDGL51294 HDGL51483 HDGL51486 HDGM51574 HDGM51575 HDGM51583 HDGP51029 HDGS52343 HDGS52358 HDGJ50055 HDGN50393 HDGM50726 HDGM50093 HDGM50146 HDGM50149 HDGM50151 HDGP51237 HDGP51290 HDGP51297 HDGQ51823 HDGQ51947 HDGJ51132 HDGJ51133 HDGJ51134 HDGJ51136 HDGJ51142 HDGJ51176 HDGJ51177 HDGJ51180 HDGJ51181 HDGJ51182 HDGJ51189 HDGJ51190 HDGL50080 HDGL50082 HDGL50123 HDGL50165 HDGR52333 HDGS50800 HDGS50812 HDGU60084 HDGU60087 HDGU60098 HDGU60157 HDGU60158 HDGU60162 HDGU60168 HDGU60598 HDGT50753 HDGT50754 HDGT50756 HDGT50757 HDGU60516 HDGU60520 HDGU60523 HDGU60527 HDGU60528 HDGU60533 HDGU60535 HDGU60540 HDGU60542 HDGU60543 HDGJ51045 HDGJ51079 HDGQ50791 HDGR52718 HDGR52936 HDGL51165 HDGL51190 HDGM51272 HDGM51289 HDGN51296 HDGN51337…
FDA’s list runs to 195,897 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.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 1, 2026.
- FDA classified it on Jun 17, 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?
- GE Medical Systems, LLC, 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 195,897 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.