Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

FDA Recall Z-2359-2026 · Posted 2026-06-18

Recalling FirmDatex-Ohmeda Inc
Recall StatusOpen, Classified
Product CodeFMT
Date Initiated2026-05-08
Product Quantity550 (367 US; 183 OUS)

Reason for Recall

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.

Firm Action

Firm began notifying customers on 5/8/2026 via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were instructed to identify affected devices by following instructions provided in the letter. Devices with affected blenders should be removed from patient use, and the customer should contact a GE HealthCare Service Representative.

Root Cause

Process control

Distribution Pattern

Pending

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123309GIRAFFE AND PANDA WARMERSOhmeda Medical · 2013-02-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑