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Open, Classified

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

FDA Recall Z-0079-2027 · Posted 2026-10-02

Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeLRP
Date Initiated2026-08-19
Product Quantity210 total kits

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Pending

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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