Cook Medical Recalls Disposable Humidification Flask: Silicone Stoppers May Dislodge
Cook Medical recalls Disposable Humidification Flasks (Reference Part Number K-MINC-CTS-S) due to a manufacturing defect that may cause silicone stoppers to dislodge or gas leaks, impairing incubator function.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Cook Medical is recalling certain Disposable Humidification Flasks that may have a manufacturing defect causing silicone stoppers to dislodge or gas leaks. This could impair the incubator's ability to deliver proper gas flow to the baby's breathing system. Read more at govinfonow.com/recall/63652-cook-medical-recalls-disposable-humidification-flask-silicone-stoppers-may-dislodge.
Source Summary by GovInfoNow · govinfonow.com/recall/63652-cook-medical-recalls-disposable-humidification-flask-silicone-stoppers-may-dislodge · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0809-2021
Cite this page
“Cook Medical Recalls Disposable Humidification Flask: Silicone Stoppers May Dislodge.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63652-cook-medical-recalls-disposable-humidification-flask-silicone-stoppers-may-dislodge. Based on FDA recall #Z-0809-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2021%22&limit=1).
Why it’s dangerous
A small percentage of these flasks have a manufacturing defect that can cause silicone stoppers to dislodge or gas to leak. This may impair gas flow to the incubator's breathing chamber, potentially affecting the baby's oxygen levels.
Who’s affected
Parents or caregivers using the Mini Incubator with the recalled flasks are most at risk. The flasks are used in medical settings for neonatal care.
How to tell if you have this one
Check for the Reference Part Number K-MINC-CTS-S and Lot Numbers listed in the recall (e.g., A1007159, A1007162, etc.). These flasks were sold with specific order numbers and lot numbers.
- Brand
Cook Medical- Category
Medical device
What to do — step by step
Check for Recalled Flasks
Look for the Reference Part Number K-MINC-CTS-S and Lot Numbers listed in the recall (e.g., A1007159, A1007162, etc.).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0809-2021 (December 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0809-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.