FDA-Device2026-10-14Class IIPROCESSING DEFECT
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
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Pending
Affected count
210 total kits
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2027More Cardinal Health recalls
- FDA-Device2026-10-07Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece fluid leakage risk
- FDA-Device2026-10-07Cardinal Health Presource Packs with Stryker tube sets recalled for handpiece leakage risk
- FDA-Device2026-10-07Cardinal Health Presource surgical kits recalled for fluid leakage risk
- FDA-Device2026-09-30Cardinal Health Presource Convenience Kits recalled for unsealed applicator packaging contamination risk
- FDA-Device2026-09-30Cardinal Health Presource Convenience Kits recalled for potentially contaminated applicators
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.