Z-0079-2027

Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084...

Name: Z-0079-2027 Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084...
Creator: Cardinal Health 200, LLC
Published: 2026-08-19
License: https://open.fda.gov/license/

Cardinal Health 200, LLC / initiated 2026-08-19 / Open, Classified

FDA source

Recall record

Recall number: Z-0079-2027
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-10-02
Recalling firm: Cardinal Health 200, LLC
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
Product code: LRP Tray, Surgical
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 root cause: Nonconforming Material/Component
Action: Firm 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 commerce: 210 total kits
Distribution: Pending
Product codes and lots: 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

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)