RegWardenFDA facility compliance records
Recall

Class II — GE Healthcare, LLC

Recalling firmGE HealthCare Technologies Inc.
Registered facilityView this company's 50 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonNon-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
ProductDATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Quantity2
DistributionUS Distribution to states of: AZ, IL NC, NH and PA.
Initiated2017-10-04
Classified2018-03-26
Terminated2020-04-10
Recall numberZ-1199-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — GE Healthcare, LLC (Z-1199-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79493/

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