Disposable Humidification Flask, Reference
Medical device recall Z-0809-2021. Published in FDA’s Enforcement Report on Jan 20, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 20, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 56250 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
56250, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: A1007159 A1007162 A1007163 A1007164 A1007160 A1007161 A1007406 A1007409 A1007405 A1007407 A1007408 A1007410 A1007662 A1007663 A1007661 A1007660 A1007838 A1007837 AC1007995 A1008104 A1008105 A1008110 A1008252 A1008253 A1008255…
Every code shown here, 1,994 characters
Lot Numbers: A1007159 A1007162 A1007163 A1007164 A1007160 A1007161 A1007406 A1007409 A1007405 A1007407 A1007408 A1007410 A1007662 A1007663 A1007661 A1007660 A1007838 A1007837 AC1007995 A1008104 A1008105 A1008110 A1008252 A1008253 A1008255 A1008254 A1008484 A1008485 A1008483 A1008491 A1008675 A1008677 A1008673 A1008674 A1008676 A1008709 A1008710 A1008714 A1008715 A1008942 A1008943 A1008946 A1008945 A1008944 A1008947 A1009066 A1009067 A1009271 A1009274 A1009275 A1009272 A1009273 A1009477 A1009478 A1009479 A1009548 A1009549 AC1009536 A1009480 A1009674 A1009675 A1010176 A1010177 A1010232 A1010234 A1010237 A1010235 A1010233 A1010236 A1010596 A1010597 A1010594 A1010595 A1010598 A1011063 A1011062 A1011058 A1011059 A1011060 A1011061 A1011294 A1011295 A1011297 A1011293 A1011296 A1011298 AC1011434 A1011533 A1011528 A1011529 A1011531 A1011532 A1011530 A1011785 A1011790 A1011787 A1011788 A1011789 A1011786 A1009065 A1012899 A1012901 A1012903 A1012902 A1012900 A1012904 A1013105 A1013108 A1013103 A1013106 A1013109 A1013104 A1013110 A1013107 AC1013142 A1013360 A1013197 A1013358 A1013194 A1013195 A1013196 A1013359 A1013357 A1013485 AC1014550 AC1014551 AC1014724 A1014791 A1014793 A1014795 A1014799 A1014792 A1015734 A1015736 A1015733 A1015735 A1015739 A1015848 A1015850 A1015740 A1015849 A1015852 A1015738 A1015851 A1015853 AC1015737 A1015968 A1015970 A1015972 A1015969 A1015971 A1015973 A1016143 A1016144 A1016141 A1016146 A1016142 A1016145 AC1016397 A1016466 A1016469 A1016467 A1016468 A1016554 A1016556 A1016553 A1016555 A1017203 A1017201 A1017202 A1017204 A1017258 A1017259 A1017260 A1017263 A1017667 A1017665 A1017666 A1017668 A1017670 A1017669 A1017902 A1017904 A1017901 A1017900 A1017903 A1017905 A1018058 A1018060 A1018057 A1018059 A1018055 A1018056 A1018181 A1018179 A1018263 A1018174 A1018180 A1018265 AC1018297 A1018420 A1018422 A1018429 A1018421 A1018423 A1018424 A1018681 A1018682 A1018680 A1018790 A1018797 A1018789 A1018951 A1018952 A1019070 A1019069 A1019155 A1019156 A1019154…
FDA’s list runs to 9,491 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 16, 2020.
- FDA classified it on Jan 8, 2021.
- FDA’s Enforcement Report published it on Jan 20, 2021.
- FDA terminated it on Nov 8, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Medical Llc, of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,491 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.