Presource Packs containing Medtronic Microstream Components: Intubation Kit
Medical device recall Z-0079-2027. Published in FDA’s Enforcement Report on Oct 14, 2026.
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 Oct 14, 2026. Copied from openFDA on Oct 21, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 210 total kits 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?
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient’s endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
FDA, Device recall enforcement reports. Released Oct 21, 2026. Updated weekly.
Which ones are recalled?
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
210 total kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 21, 2026. Updated weekly.
Codes to check against yours
AN23366084 UDI-DI 10197106950074 Kit lot 40711 AN23366085 UDI-DI 10198956177987 Kit lot 46520 AN2336608H UDI-DI 10197106159828 Kit lots 20866 23139 24264 25795 27111 27899 29023 29488 30527 31037 31698 32777 33326 AN2336608J UDI-DI…
Every code shown here, 513 characters
AN23366084 UDI-DI 10197106950074 Kit lot 40711 AN23366085 UDI-DI 10198956177987 Kit lot 46520 AN2336608H UDI-DI 10197106159828 Kit lots 20866 23139 24264 25795 27111 27899 29023 29488 30527 31037 31698 32777 33326 AN2336608J UDI-DI 10197106704035 Kit lots 33461 33624 35231 35535 35689 36554 36600 36825 38327 38891 40511 41864 43975 44933 45972 47547 47897 48088 48528 49440 OMSVM4166A UDI-DI 10198956162259 Kit Lots 47765 50521 53221 53929 54565 54644 AN2336608G UDI-DI 10197106052105 Kit lots 18464 18569 19224
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.
Pending
These words name no state.
FDA, Device recall enforcement reports. Released Oct 21, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Aug 19, 2026.
- FDA classified it on Oct 2, 2026.
- FDA’s Enforcement Report published it on Oct 14, 2026.
FDA, Device recall enforcement reports. Released Oct 21, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health 200, LLC, of Waukegan, IL.
- 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 21, 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.”
- 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 21, 2026 and checked Oct 21, 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 21, 2026.