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Class IIMedical device recallOngoing

Presource Packs containing Medtronic Microstream Components: Intubation Kit recall

Recalled by Cardinal Health 200, LLC · Part of Cardinal Health Inc of Waukegan, IL · FDA report 10/14/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Ongoing
Recall started
08/19/2026
Distribution
See below

Reason for recall

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.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product
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
Lot and code info
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
Quantity
210 total kits
Recall number
Z-0079-2027
Event ID
99801
Initiated by
Voluntary: Firm initiated

Where it was distributed

Pending

Recall timeline

  1. 08/19/2026Firm started the recall
  2. 10/02/2026FDA classified it as Class II
  3. 10/14/2026Published in the FDA enforcement report

More recalls from Cardinal Health 200

Frequently asked questions

Why was Presource Packs containing Medtronic Microstream Components: Intubation Kit recalled?
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.
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Is this recall still active?
The FDA lists the recall as ongoing. The recall is still in progress.

Subsidiary of Cardinal Health Inc (CAH) · financials and records from other agencies

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/14/2026 · Do not rely on openFDA to make decisions regarding medical care