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FDA-Device2026-04-08Class II

Airway Exam Kit, DYKE1796

Medline Industries, LP
Hazard
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Sold states
US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Affected count
14,379 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Airway Exam Kit, DYKE1796

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1705-2026

Original summary

Airway Exam Kit, DYKE1796 Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. UDI-DI 10193489874716 (ea) 40193489874717 (case) Lots 24CBT023 24FBB701 24LBL343 25GBP141 Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Affected quantity: 14,379 kits total

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