FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline BAL and ENDO kits recalled for Olympus biopsy valve rubber fragments

OTHERNationwide distribution

Stop using recalled Medline respiratory kits

Medline kits containing Olympus biopsy valves may have rubber fragments that can detach inside the valve. These fragments could enter a patient's airway and require removal, or cause inflammation and breathing problems. Olympus is investigating complaints about this issue.

  • Stop using the recalled BAL KIT (DYNDA2137B) and ENDO KIT (DYKE1915) immediately
  • Check the lot numbers on your kits against the FDA notice to confirm if yours are affected
  • Contact Medline or your supplier for instructions on return or replacement
  • Review patient records if kits were already used and watch for any respiratory complications
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

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