GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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. Affected customers were…"
Plain-English summary
GE Healthcare Giraffe Omnibed Carestation CS1 infant incubator and warmer units are the subject of this recall, affecting 769 units manufactured under prior manufacturing practices and distributed worldwide.
Prior to current manufacturing standards, newly manufactured incubators could release elevated levels of airborne formaldehyde during clinical use. The formaldehyde exposure would rapidly decrease over approximately one week of operation. Sensory irritation of the eyes is identified as the most sensitive health effect at the lowest exposure concentrations.
The manufacturer notified affected customers in June 2023 to operate incubators for one week to allow potential off-gassing of residual airborne formaldehyde. Healthcare facilities should identify whether their incubators match the affected model numbers and batch codes listed in the official FDA recall notice and follow the manufacturer's off-gassing guidance.
The recalled product
- Product
- GE 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)…
- Manufacturer
- DATEX--OHMEDA, INC.
- Affected units
- 769
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 2082844-001-01040418
- UDI: (01)00840682116862(21)TABC70024(11)230203
- (01)00840682116862(21)TABC70035(11)230207
- (01)00840682116862(21)TABC70037(11)230207
- (01)00840682116862(21)TABC70038(11)230207
- (01)00840682116862(21)TABC70045(11)230208
- (01)00840682116862(21)TABC70052(11)230209
- (01)00840682116862(21)TABC70054(11)230209
- (01)00840682116862(21)TABC70056(11)230209
- (01)00840682116862(21)TABC70060(11)230209
- (01)00840682116862(21)TABC70064(11)230210
- (01)00840682116862(21)TABC70068(11)230210
- (01)00840682116862(21)TABC70069(11)230210
- (01)00840682116862(21)TABC70070(11)230210
- 2) 2082844-001-01046784
- UDI: (01)008406821168622(21)TAB23060007SA(11)230209
- (01)008406821168622(21)TAB23060008SA(11)230209
- (01)008406821168622(21)TAB23060009SA(11)230209
- (01)008406821168622(21)TAB23060010SA(11)230209
- (01)008406821168622(21)TAB23060011SA(11)230209
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by DATEX--OHMEDA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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