FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline bronchoscopy kits with Olympus biopsy valves recalled for rubber fragment detachment risk

OTHERNationwide distributionMedical devices

What this means

Medline convenience kits containing Olympus biopsy valves may have defective valves that shed rubber fragments during use. These fragments could lodge in a patient's airway, potentially requiring removal and causing inflammation or breathing problems.

  • Check your inventory for the three affected kit models: BRONCH PACK (DYKE2096), NON MB BRONCHOSCOPY CCH LH PK (DYNJT6182), and PULMONARY BRONCH PACK (DYNDA2861A)
  • Do not use any kits matching the recalled lot numbers listed in the FDA notice
  • Contact Medline or Olympus for replacement kits or instructions
  • Report any valve defects or patient incidents to the FDA MedWatch program
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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 convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1706-2026

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