Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an…
Medical device recall Z-2476-2026. 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
- 23430 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 Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
23430 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 010084068211686221; Serial Numbers: TAB24430068SA TAB24430069SA TAB24430070SA TAB24430071SA TAB26011006SA TAB26011009SA TAB26021001SA TAB26061022SA TABW63370 TAB24300033SA TABV60214 TABW63378 TAB24240010SA TABV62327 TABA70043…
Every code shown here, 1,992 characters
UDI-DI: 010084068211686221; Serial Numbers: TAB24430068SA TAB24430069SA TAB24430070SA TAB24430071SA TAB26011006SA TAB26011009SA TAB26021001SA TAB26061022SA TABW63370 TAB24300033SA TABV60214 TABW63378 TAB24240010SA TABV62327 TABA70043 TABA70053 TABA70054 TABA70055 TABZ72515 TABV60081 TABV60219 TABV60221 TABV60223 TABV60224 TAB25351023SA TAB25501502SA TAB25501503SA TAB25501530SA TAB25501531SA TAB26021501SA TAB26021503SA TAB26101502SA TAB26101503SA TAB26101507SA TAB26101509SA TAB26101510SA TAB26101511SA TAB26101512SA TAB26101513SA TAB26101515SA TAB26101516SA TAB26101517SA TAB26101519SA TAB26101520SA TAB26101521SA TABX63854 TABX63855 TABX63856 TAB25111019SA TAB24160010SA TABY70926 TABY70987 TABX63393 TAB24280002SA TABV60007 TABV60203 TABW63326 TABX62677 TABX62757 TABX63717 TABX63718 TABY71177 TAB24180045SA TAB24180046SA TAB24180047SA TAB24280001SA TAB25081073SA TAB25081074SA TABB70452 TABB70464 TABB70550 TABB70572 TABX63665 TABX63769 TABX63776 TAB24330009SA TAB24330010SA TAB24330011SA TAB24330012SA TAB24330013SA TAB24330014SA TAB24330015SA TAB24330016SA TAB24330017SA TAB24330018SA TAB24330021SA TAB24430028SA TAB25101068SA TAB25101069SA TAB25101070SA TAB25101071SA TAB25101072SA TAB25101073SA TAB25101074SA TAB25101075SA TAB25101076SA TAB25101077SA TAB25101078SA TAB25101079SA TAB25101080SA TAB25101081SA TAB25101082SA TAB25101083SA TAB25111000SA TAB25111001SA TAB25111002SA TAB25111003SA TAB25111004SA TAB25111009SA TAB25111010SA TAB25111011SA TAB25111012SA TAB25111013SA TAB25421013SA TAB25421014SA TAB25421015SA TAB25421016SA TABX62269 TABZ70640 TAB26061051SA TAB26071039SA TAB26081028SA TAB26081035SA TAB26081042SA TABW62610 TABW62689 TABW62731 TABX62268 TABX63359 TABX63374 TABX63603 TABX63614 TABX63616 TABA71644 TABA71768 TABW63180 TABZ70669 TAB24500004SA TAB24500005SA TAB24500006SA TAB24500007SA TAB25121048SA TABV61088 TABV61128 TABV61129 TABV61130 TABV61295 TABV61301 TABV61306 TABV61313 TABV61326 TABV61333 TABV61335 TABV61336 TABV61338 TABV61350 TABV61352 TABV61355…
FDA’s list runs to 269,585 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 269,585 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.