The Recall Desk

FDA (Devices) recall action 95456

DATEX--OHMEDA, INC. recalled 2 products on 2024-11-06

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-11-06
Critical
0
Units
993

Why these products were recalled

Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2024-11-06

    GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing

    GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.

    Product
    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-11-06

    GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure

    GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.

    Product
    GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2
    Category
    Distribution
    0 states