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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health Presource

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 Class 2 Device Recall Cardinal Health Presourcesee related information
Date Initiated by FirmAugust 19, 2026
Date PostedOctober 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0079-2027
Recall Event ID 99801
Product Classification Tray, surgical - Product Code LRP
ProductPresource 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
Code Information 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
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact
847-887-5500
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm began notifying affected customers on August 19, 2026 via letters titled "Product Advisory." Customers were provided with the Medtronic/Stryker "URGENT Medical device correction UPDATE" letter and instructed to alert all affected clinicians. Customers were informed that in September 2025, Medtronic issued an update to the Instructions for Use (IFU) for the affected devices to include a relevant Adverse Events section. Customers may continue using the affected devices. Product does not need to be returned or discarded.
Quantity in Commerce210 total kits
DistributionPending
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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