Drugs & medicalClass II

DATEX--OHMEDA, INC. recalls Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f.…

GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe…

Read the official notice →
Date
2023-07-12
Country
United States
Brand
Datex-Ohmeda
Product
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f.…
Classification
Class II
Units
Worldwide distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Datex-Ohmeda recalls

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

    Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling…

    FDA · DeviceDatex-Ohmeda, Inc.Worldwide - US Nationwide distribution.Official notice →
  3. 2026-06-24
  4. US
    Drugs & medicalClass I

    Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001,…

    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…

    FDA · DeviceDatex-Ohmeda IncPendingOfficial notice →
  5. 2024-11-06
  6. US
    Drugs & medicalClass I

    DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…

    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.…

    FDA · DeviceDATEX--OHMEDA, INC.worldwideOfficial notice →
  7. 2024-10-30
  8. US
    Drugs & medicalClass I

    Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…

    Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

    FDA · DeviceDatex-Ohmeda, Inc.Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice →
  9. 2024-10-23
  10. US
    Drugs & medicalClass I

    DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed; neo natal incubator

    GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This…

    FDA · DeviceDATEX--OHMEDA, INC.Worldwide distribution.Official notice →
  11. 2024-02-07
  12. US
    Drugs & medicalClass I

    Datex-Ohmeda, Inc. recalls EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002

    GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These…

    FDA · DeviceDatex-Ohmeda, Inc.WorldwideOfficial notice →
All 7 Datex-Ohmeda recalls →

Other drugs & medical recalls in the United States

  1. 2023-07-19
  2. US
  3. 2023-07-12
  4. US
    Drugs & medicalClass II

    Philips Respironics, Inc. recalls Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

    There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

    FDA · DevicePhilips Respironics, Inc.Foreign Distribution: Korea.Official notice →
  5. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

    The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

    FDA · DeviceWright Medical Technology, Inc.There was no U.S. distribution, including government and military. Foreign…Official notice →
  6. US
    Drugs & medicalClass II

    Becton Dickinson & Co. recalls BD Synapsys Informatics Solution, Catalog Number 444150

    There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using save actions (Skip, Final…

    FDA · DeviceBecton Dickinson & Co.US States: CA, CO, IA, IL, MI, MN, MO, NY, OH, OK, SC, TN, TX, UT, WI.…Official notice →
  7. US
    Drugs & medicalClass II

    Pro-Dex Inc recalls KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

    Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be…

    FDA · DevicePro-Dex IncUS: FLOfficial notice →
  8. US
    Drugs & medicalClass II

    TELEFLEX LLC recalls Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor

    There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

    FDA · DeviceTELEFLEX LLCNationwide and Australia, Canada, S. Korea, SingaporeOfficial notice →
See all drugs & medical recalls →