DATEX--OHMEDA, INC.: Giraffe Incubators and Omnibeds Recalled for Formaldehyde Exposure

Agency Publication Date: October 31, 2024

Summary

Datex-Ohmeda, Inc. is recalling 993 GE Healthcare Giraffe Omnibed Carestation CS1 and Giraffe Incubator Carestation CS1 units manufactured in the United States. These medical devices, used to provide a controlled environment for infants, were found to potentially release higher than acceptable levels of airborne formaldehyde during their first week of clinical use. The issue stems from manufacturing practices that have since been updated, and levels typically decrease rapidly after the first week of operation.

Risk

Exposure to elevated levels of airborne formaldehyde can cause sensory irritation, most notably to the eyes. This irritation is the most sensitive indicator of exposure and occurs at the lowest concentrations of the chemical.

What You Should Do

Check your medical facility's inventory for GE Healthcare Giraffe Omnibed Carestation CS1 or Giraffe Incubator Carestation CS1 units.
Verify the model and serial numbers against the affected lists, including model numbers such as 2082844-001-01040418, 2082844-002-01040417, and various other configurations listed in the recall documentation.
Identify affected units by checking the Unique Device Identifier (UDI) codes on the product label, such as (01)00840682116862(21)TABC70024(11)230203 or (01)00840682116855(21)TAAC70003(11)230106.
If you have a newly manufactured unit from the affected batch, run the incubator or Omnibed for at least one week prior to clinical use to allow any residual formaldehyde to 'off-gas' safely.
Contact your healthcare provider or GE Healthcare/Datex-Ohmeda at 1-800-437-1171 for further technical instructions or to confirm if your specific unit requires the off-gassing procedure.
For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Pre-use off-gassing procedure

How to: Run newly manufactured incubators for one week prior to clinical use to allow residual airborne formaldehyde to decrease.

Affected Products

Product: GE Healthcare Giraffe Omnibed Carestation CS1

Model / REF (65):

2082844-001-01040418

2082844-001-01046784

2082844-001-01052324

2082844-001-01052572

2082844-001-01055337

2082844-001-01065693

2082844-001-01069008

2082844-001-01073750

2082844-001-01086553

2082844-001-01089393

2082844-001-01090414

2082844-001-01092632

2082844-001-01111482

2082844-001-01115741

2082844-001-01122391

2082844-001-01128579

2082844-001-01128725

2082844-001-01131573

2082844-001-01140642

2082844-001-01165870

2082844-001-100397

2082844-001-100676

2082844-001-100740

2082844-001-100743

2082844-001-100744

2082844-001-101075

2082844-001-101149

2082844-001-101199

2082844-001-101202

2082844-001-101203

2082844-001-101356

2082844-001-101366

2082844-001-101656

2082844-001-102136

2082844-001-102589

2082844-001-102858

2082844-001-526493

2082844-001-533346

2082844-001-570904

2082844-001-615985

2082844-001-616544

2082844-001-674814

2082844-001-701655

2082844-001-704407

2082844-001-709042

2082844-001-857748

2082844-001-888278

2082844-001-941288

2082844-001-965539

2082844-001-978713

Lot Numbers:

UDI (01)00840682116862...

Product: GE Healthcare Giraffe Incubator Carestation CS1

Model / REF:

2082844-002-01040417

2082844-002-01044956

2082844-002-01058424

2082844-002-01069017

2082844-002-01089666

2082844-002-01090474

2082844-002-01091269

2082844-002-01093489

2082844-002-01113262

2082844-002-01113711

2082844-002-01123085

2082844-002-01123918

2082844-002-01128966

2082844-002-01133042

2082844-002-01146447

2082844-002-100205

2082844-002-100749

2082844-002-100752

2082844-002-100995

2082844-002-101425

2082844-002-523548

2082844-002-529928

2082844-002-594800

2082844-002-643544

2082844-002-925841

2082844-002-965540

2082844-002-982916

2082844-002-983420

2082844-002-993905

2082844-002-995018

2082844-002-995799

2082844-002-998943

Lot Numbers:

UDI (01)00840682116855...

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95456

Status: Resolved

Manufacturer: DATEX--OHMEDA, INC.

Sold By: Hospital supply channels; Direct medical distribution

Manufactured In: United States

Units Affected: 2 products (769 units; 224 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical facility's inventory for GE Healthcare Giraffe Omnibed Carestation CS1 or Giraffe Incubator Carestation CS1 units.

Verify the model and serial numbers against the affected lists, including model numbers such as 2082844-001-01040418, 2082844-002-01040417, and various other configurations listed in the recall documentation.

Identify affected units by checking the Unique Device Identifier (UDI) codes on the product label, such as (01)00840682116862(21)TABC70024(11)230203 or (01)00840682116855(21)TAAC70003(11)230106.

If you have a newly manufactured unit from the affected batch, run the incubator or Omnibed for at least one week prior to clinical use to allow any residual formaldehyde to 'off-gas' safely.

Contact your healthcare provider or GE Healthcare/Datex-Ohmeda at 1-800-437-1171 for further technical instructions or to confirm if your specific unit requires the off-gassing procedure.

For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: GE Healthcare Giraffe Omnibed Carestation CS1

Model / REF (65):

2082844-001-01040418

2082844-001-01046784

2082844-001-01052324

2082844-001-01052572

2082844-001-01055337

2082844-001-01065693

2082844-001-01069008

2082844-001-01073750

2082844-001-01086553

2082844-001-01089393

2082844-001-01090414

2082844-001-01092632

2082844-001-01111482

2082844-001-01115741

2082844-001-01122391

2082844-001-01128579

2082844-001-01128725

2082844-001-01131573

2082844-001-01140642

2082844-001-01165870

2082844-001-100397

2082844-001-100676

2082844-001-100740

2082844-001-100743

2082844-001-100744

2082844-001-101075

2082844-001-101149

2082844-001-101199

2082844-001-101202

2082844-001-101203

2082844-001-101356

2082844-001-101366

2082844-001-101656

2082844-001-102136

2082844-001-102589

2082844-001-102858

2082844-001-526493

2082844-001-533346

2082844-001-570904

2082844-001-615985

2082844-001-616544

2082844-001-674814

2082844-001-701655

2082844-001-704407

2082844-001-709042

2082844-001-857748

2082844-001-888278

2082844-001-941288

2082844-001-965539

2082844-001-978713

Lot Numbers:

UDI (01)00840682116862...

Product: GE Healthcare Giraffe Incubator Carestation CS1

Model / REF:

2082844-002-01040417

2082844-002-01044956

2082844-002-01058424

2082844-002-01069017

2082844-002-01089666

2082844-002-01090474

2082844-002-01091269

2082844-002-01093489

2082844-002-01113262

2082844-002-01113711

2082844-002-01123085

2082844-002-01123918

2082844-002-01128966

2082844-002-01133042

2082844-002-01146447

2082844-002-100205

2082844-002-100749

2082844-002-100752

2082844-002-100995

2082844-002-101425

2082844-002-523548

2082844-002-529928

2082844-002-594800

2082844-002-643544

2082844-002-925841

2082844-002-965540

2082844-002-982916

2082844-002-983420

2082844-002-993905

2082844-002-995018

2082844-002-995799

2082844-002-998943

Lot Numbers:

UDI (01)00840682116855...