Disposable Humidification Flask — Class II medical device recall Z-0809-2021
Terminated recall by Cook Medical Llc, reported 2021-01-20, distributed nationwide. A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the
| Recall number | Z-0809-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Medical Llc, Bloomington, IN, United States |
| Recall initiated | 2020-12-16 |
| Classified | 2021-01-08 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 56,250 |
| Reason classes | packaging |
| Lot numbers | A1007159, A1007160, A1007161, A1007162, A1007163, A1007164, A1007405, A1007406, A1007407, A1007408, A1007409, A1007410, A1007660, A1007661, A1007662, A1007663, A1007837, A1007838, A1008104, A1008105, A1008110, A1008252, A1008253, A1008254, A1008255, A1008483, A1008484, A1008485, A1008491, A1008673, A1008674, A1008675, A1008676, A1008677, A1008709, A1008710, A1008714, A1008715, A1008942, A1008943 and 460 more |
Product
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0809-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.