Class II — Cook Medical Llc
| Recalling firm | COOK MEDICAL |
|---|---|
| Registered facility | COOK MEDICAL LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator. |
| Product | Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 |
| Quantity | 56250 |
| Distribution | US Nationwide |
| Initiated | 2020-12-16 |
| Classified | 2021-01-08 |
| Terminated | 2023-11-08 |
| Recall number | Z-0809-2021 |
| Initiation | Voluntary: 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 — Cook Medical Llc (Z-0809-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86965/
Alerts for COOK MEDICAL
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.