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Ongoing FDAEvent 99801 (13 days ago)

Presource Packs Containing Medtronic Microstream Components

Presource Packs containing Medtronic Microstream Components can cause difficulty disconnecting an adapter, leading to treatment delay and unintended extubation.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Cardinal Health 200, LLC began a recall on August 19, 2026, of Presource Packs containing Medtronic Microstream Components, including Intubation Kit, Intubating Bag Kit, and Intubation UH Kit, totaling 210 kits.

Medtronic issued an update to the Instructions for Use of these components due to 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, with the potential for respiratory failure, hypoxia, aspiration, or low oxygen saturation.

Summary by Recall Canary from the FDA notice.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI and lot code are listed under that product.

  1. Presource Packs containing Medtronic Microstream Components

    UDI-DI
    • 10197106950074
    • 10198956177987
    • 10197106159828
    • 10197106704035
    • 10198956162259
    • 10197106052105
    Lot
    • 40711
    • AN23366085
    • 46520
    • AN2336608H
    • 20866
    • 23139
    • 24264
    • 25795
    • 27111
    • 27899
    • 29023
    • 29488
    • 30527
    • 31037
    • 31698
    • 32777
    • 33326
    • AN2336608J
    • 33461
    • 33624
    • 35231
    • 35535
    • 35689
    • 36554
    • 36600
    • 36825
    • 38327
    • 38891
    • 40511
    • 41864
    • 43975
    • 44933
    • 45972
    • 47547
    • 47897
    • 48088
    • 48528
    • 49440
    • OMSVM4166A
    • 47765
    • 50521
    • 53221
    • 53929
    • 54565
    • 54644
    • AN2336608G
    • 18464
    • 18569
    • 19224

Details

Company began the recall
Event ID
99801
Company
Cardinal Health 200, LLC
Hazard
Device defect
Quantity recalled
210 total kits

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

All recalls from Cardinal Health 200, LLC

Other device defect recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration