FDA recall Z-1707-2026

Medline Industries, LP · Class II · device

Product

THORACIC ROBOTS, DYNJ908777B

Reason for recall

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.

Distribution

US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.

Key facts

Status
Ongoing
Initiation date
2026-02-16
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

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