FDA Class I Recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator… by Datex-Ohmeda Inc — Recall Details

Key facts

What consumers should do

Facilities and clinicians holding an affected lot or unit should stop using it for the indication described in the recall notice and quarantine remaining stock pending instructions from Datex-Ohmeda Inc. FDA recall records for devices typically direct the recalling firm to notify known accounts (hospitals, distributors, clinics) directly with a recall letter describing the specific corrective action — replacement, field correction, or return. Anyone who received 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 through a distributor rather than directly from Datex-Ohmeda Inc should still confirm with their supplier whether their specific lot or serial number is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Datex-Ohmeda Inc directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA's most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case — it reflects FDA's assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because Class I is reserved for the highest-risk defects, professionals and consumers handling an affected lot are generally advised to treat the recall as time-sensitive rather than routine.

Datex-Ohmeda Inc’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Datex-Ohmeda Inc: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Who should I contact about this recall?

Contact Datex-Ohmeda Inc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Datex-Ohmeda Inc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Datex-Ohmeda Inc, including 3 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2357-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions