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.…
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Datex-Ohmeda
- Product
- GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3)…
- Classification
- Class I
- Units
- worldwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2026-09-23
USDatex-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…
- 2026-06-24
- US
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…
- 2024-10-30
- US
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 → - 2024-10-23
- US
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…
- 2024-02-07
- US
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…
- 2023-07-12
- US
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…
Other drugs & medical recalls in the United States
- 2024-11-06
- US
Baxter Healthcare Corporation recalls a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208,…
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide. There was government and military…Official notice → - US
Smiths Medical ASD Inc. recalls CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory…
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery…
- US
Percussionaire Corporation recalls Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway…
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a…
FDA · DevicePercussionaire CorporationU.S.: PA, AR, MI, CA, TX, OH, NY, FL, IL, NE, OR, GA, WI, MO, OK, AL, WV, MT,…Official notice → - US
Maquet Cardiovascular, LLC recalls VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution. US Nationwide. Brazil, China, and Hong Kong.Official notice → - US
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15,…
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- US
BLI International, Inc. recalls Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Superpotent Drug: Stability failure for assay at 6 months test time-point.
FDA · DrugBLI International, Inc.Product was shipped to two private label customers ( OH & MO) as a final…Official notice →