THORACIC ROBOTS, DYNJ908777B
Published April 8, 2026 · Recall initiated: February 16, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
- Lot
- UDI-DI 10198459269196 (EA) 40198459269197 (CS) LOTS 25EBD732 25GBG733 25IBQ613 25JBD457 25KBT352 26ABA235 26ABP735
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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