Presource Packs containing Medtronic Microstream Components recallZ-0079-2027 · Cardinal Health 200, LLC · initiated Aug 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0079-2027
- Status
- Open, Classified
- Initiated by the company
- Aug 19, 2026
- Posted by the FDA
- Oct 2, 2026
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 210 total kits
- Product code
- LRP
- Distribution
- Pending
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- CARDINAL HEALTH AN2336608GCardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
- CARDINAL HEALTH AN2336608HCardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
- CARDINAL HEALTH AN2336608JCardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
- CARDINAL HEALTH AN23366084Cardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
- CARDINAL HEALTH OMSVM4166ACardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
- CARDINAL HEALTH AN23366085Cardinal Health 200, LLC · TRAY, SURGICAL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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