FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline bronchoscopy and laryngoscopy kits recalled for Olympus biopsy valve rubber fragments

OTHERNationwide distribution

Stop using affected Medline bronchoscopy kits

Medline kits containing Olympus biopsy valves may have rubber fragments that can detach inside the valve. These fragments could lodge in a patient's airways during a procedure, potentially requiring removal and causing inflammation or reduced oxygen levels.

  • Check if your kit matches one of the four recalled models and lot numbers listed in the recall
  • Stop using any affected kits immediately
  • Contact Medline or your healthcare facility's supply chain for instructions on returns or replacements
  • Report any fragments found or patient complications to Medline or the FDA
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. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1709-2026

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