Key facts
| Recalling firm | GE Medical Systems, LLC |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX |
| Classification | Class II |
| Recall number | Z-2476-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | 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. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX -- and the recall number Z-2476-2026. If it matches, stop using or distributing it and contact GE Medical Systems, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is GE Medical Systems, LLC and the affected product is described in FDA's record as: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2476-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
GE Medical Systems, LLC’s FDA history
Argus HQ has recorded 15 total FDA actions tied to GE Medical Systems, LLC: 0 warning letters, 15 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX) and recall number Z-2476-2026, then follow GE Medical Systems, LLC's recall instructions.
- Has GE Medical Systems, LLC had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 15 total FDA actions tied to GE Medical Systems, LLC, including 15 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2476-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
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Related enforcement actions
Full FDA history for GE Medical Systems, LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1,… by GE Medical Systems, LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-ge-medical-systems-llc-z-2476-2026
"FDA Recall Database: Class II Recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1,… by GE Medical Systems, LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-ge-medical-systems-llc-z-2476-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1,… by GE Medical Systems, LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-ge-medical-systems-llc-z-2476-2026.
@misc{argushq_argushq_ai_recall_fda_recall_ge_medical_systems_llc_z_2476_2026_2026,
title = {FDA Recall Database: Class II Recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1,… by GE Medical Systems, LLC},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-ge-medical-systems-llc-z-2476-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗