← FDA ENFORCEMENT
Z-1782-2026Class II

Cook Incorporated

Recalling firm
Cook Incorporated
Product type
Device
Status
Ongoing
Report date
2026-04-15
Distribution
Worldwide distribution.
Firm state
IN
Product quantity
95 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Product description

COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

Code / lot info

Reference Part Number C-CAE-14.0-83-EXTU, UDI (01)00827002240735(17)270509(10)16010654, Lot Number 16010654.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.