Recall Register

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Datex-Ohmeda, Inc.

FDA recalling firm · 9 enforcement events · 30 product records · 2017–2026 · WI

Datex-Ohmeda, Inc. has 9 FDA enforcement events on this register (30 product records) between 2017 and 2026: 9 device; the busiest year was 2023 with 3.

56% of its events are Class I; the most common class is Class I (5). 6 events are listed as ongoing; the recalling firm's address is in WI.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Jul 2026Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000DeviceClass II4Ongoing
8 May 2026Giraffe 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 MaintenanceDeviceClass I3Ongoing
3 Sep 2024GE Heathcare Giraffe OmniBed; neo natal incubatorDeviceClass I2Ongoing
12 Jul 2024Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.DeviceClass I11Ongoing
29 Dec 2023EVair air compressor, model numbers: M1230849 and M1230847DeviceClass I3Ongoing
6 Jun 2023GE 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) 2082844-001-01069008; 8) 2082844-001-01073750; 9)…DeviceClass I2Completed
19 May 2023Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G…DeviceClass II3Ongoing
28 Jun 2018The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.DeviceClass II1Terminated
8 Dec 2017CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,…DeviceClass II1Terminated

By type and class

Device9
Class I5
Class II4

Class I: 56% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for Datex-Ohmeda, Inc. by year initiated.

Questions and answers

How many FDA recalls has Datex-Ohmeda, Inc. had?

9 enforcement events (30 product records) on this register, 2017–2026: 9 device.

Are any Datex-Ohmeda, Inc. recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Datex-Ohmeda, Inc. recalls?

5 Class I, 4 Class II. 56% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.