Drug & Device Safety Atlas

FDA recall record · openFDA

Datex-Ohmeda, Inc.

21 FDA recalls on record (2023–2024) — 21 device. 21 still ongoing.

18
Class I (most serious)
3
Class II
0
Class III
21
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Commo 11
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compress 3
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on t 3
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that 2
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufac 2

Recalls

Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat Class I 2024-07-12 GE Heathcare Giraffe OmniBed; neo natal incubator Class I 2024-09-03 Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to Class I 2024-07-12 Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v Class I 2024-07-12 Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p Class I 2024-07-12 Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie Class I 2024-07-12 Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to Class I 2024-07-12 Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati Class I 2024-07-12 Amingo. OUS only. Class I 2024-07-12 Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t Class I 2024-07-12 Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY Class I 2024-07-12 Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t Class I 2024-07-12 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator Class I 2024-09-03 GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828 Class I 2023-06-06 EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 Class I 2023-12-29 EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Class I 2023-12-29 EVair air compressor, model numbers: M1230849 and M1230847 Class I 2023-12-29 GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 208 Class I 2023-06-06 Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M113582 Class II 2023-05-19 Beside panel FRU (Field Replacement Units) Kits Class II 2023-05-19 Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094 Class II 2023-05-19

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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