Recall Z-0079-2027 ยท LRP Tray, Surgical
Cardinal Health 200, LLC
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
| Date | Oct 2, 2026 (initiated Aug 19, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 | 210 total kits |
| Distribution | Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.