FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline Airway Exam Kit recalled for rubber fragments in Olympus biopsy valves

OTHERNationwide distributionMedical devices

What this means

Medline's Airway Exam Kit contains Olympus biopsy valves that may shed rubber fragments. These fragments can lodge in a patient's airway and may require removal. This could cause inflammation, low oxygen levels, or extend the procedure time.

  • Stop using Airway Exam Kit model DYKE1796 immediately, especially lots 24CBT023, 24FBB701, 24LBL343, and 25GBP141.
  • Contact Medline or your device distributor for instructions on returning or disposing of affected kits.
  • If a kit was already used on a patient, notify the patient's healthcare provider so they can monitor for symptoms or complications.
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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
Airway Exam Kit, DYKE1796

Official notice

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

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