Datex-Ohmeda Inc recalls
Every recall we track for Datex-Ohmeda Inc — 30 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Datex-Ohmeda Inc dropped to zero in 2025 (0, down from 13 in 2024).
All FDA recall records for Datex-Ohmeda Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 1 | 0 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 3 | 5 | 0 | 8 |
| 2024 | 0 | 12 | 1 | 0 | 13 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 4 | 3 | 0 | 7 |
What to do if you have a recalled Datex-Ohmeda Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Datex-Ohmeda Inc recalls
9 shown- Use cautionMedical device
Datex-Ohmeda, Inc. recalls Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda recalls Aisys anesthesia systems with specific part numbers due to risk of automatic transition to Alternate O2 control, which may interrupt anesthetic delivery and require clinician intervention to prevent decreased anesthetic effect.
Datex-OhmedaJul 30, 2026 - Lower riskMedical device
Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers:
Datex-Ohmeda Inc is a leading medical device manufacturer specializing in critical care monitoring systems, patient monitoring equipment, and advanced medical technology solutions.
Datex-OhmedaMay 8, 2026 - Use cautionMedical device
DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed; neo natal incubator
GE HealthCare recalls Giraffe OmniBed neonatal incubators due to potential loose doors from improper screw tightening. Affected units may require repair to prevent injury risks during use.
Datex-Ohmed: GE HealthCareSep 3, 2024 - Use cautionMedical device
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and
Datex-Ohmeda recalls Aisys CS2 anesthesia machines with Et Control due to risk of patient injury if breathing circuit limb is mistakenly connected to Auxiliary Common Gas Outlet port. All units with AGCO option affected.
Datex-Ohmed: AisysJul 12, 2024 - Lower riskMedical device
Datex-Ohmeda, Inc. recalls EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Datex-Ohmeda recalls EVair 03 (Jun-air) air compressors (models 1609000, 1609002) due to potential formaldehyde exposure when used with specific ventilators at high temperatures and low flow rates.
Datex-OhmedaDec 29, 2023 - Lower riskMedical device
DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2)
Datex-Ohmeda recalls GE Healthcare Giraffe Incubator Carestation CS1 infant incubators with specific model numbers due to potential formaldehyde exposure during initial use. The risk is sensory irritation, not serious injury.
Datex-OhmedaJun 6, 2023 - Lower riskMedical device
DATEX--OHMEDA, INC. recalls Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e.
Datex-Ohmeda recalls Giraffe OmniBed Carestation CS1 models with potential incorrect secondary latch on NE/NW bedside panels. Affected units may have safety risk during use.
Datex-OhmedaMay 19, 2023 - Use cautionMedical device
Datex-Ohmeda, Inc. recalls The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in
Datex-Ohmeda recalls neonatal flow sensor cables for CARESCAPE R860 and ENGSTROM devices due to missing connector housing exposing wires. Affected units have specific serial numbers and model numbers.
Datex-OhmedaJun 28, 2018 - Lower riskMedical device
Datex-Ohmeda, Inc. recalls CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to
Datex-Ohmeda Inc is a leading manufacturer of medical equipment, including ventilators, monitors, and patient care systems. Their products are designed to improve patient outcomes and healthcare delivery.
Datex-Ohmeda IncDec 8, 2017
Datex-Ohmeda Inc recall questions
How many recalls has Datex-Ohmeda Inc had?
30 recalls from Datex-Ohmeda Inc are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Datex-Ohmeda Inc recall?
Datex-Ohmeda, Inc. recalls Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000, dated Jul 30, 2026. Every Datex-Ohmeda Inc recall is listed on this page, newest first.
What should I do if I have a recalled Datex-Ohmeda Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Datex-Ohmeda Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.