Recall Weekly← all recalls
FDA-Device2026-04-08Class II

Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

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
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2026

Original summary

Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915 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. 1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319 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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief