COOK BIOTECH, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Catheter, IrrigationProduct code GBX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200
Recalls & enforcement
- Class IIOngoing2024-11-22Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Class IIOngoing2024-08-07Products expire prior to the expiration date printed on the product labeling
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “COOK BIOTECH, INC. (FEI 3002340648) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002340648-cook-biotech-inc/
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