FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medline thoracic robot kits recalled for defective Olympus biopsy valves

OTHERNationwide distributionMedical devices

What this means

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

  • Check if your kit matches lot numbers 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235, or 26ABP735
  • Stop using affected kits immediately
  • Contact Medline or Olympus for instructions on replacement or return
  • Report any patient injuries 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
THORACIC ROBOTS, DYNJ908777B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1707-2026

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