Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DY

FDA device recall Z-1709-2026 · posted 2026-04-01 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

Action taken

Firm notified customers on 2/16/26. Consignees were provided with a copy of Olympus's notification, which includes reminders to follow the IFU. According to the firm, the component can continue to be utilized by the customer, along with the remainder of the kit.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OGR

Quantity affected

14,379 kits total

Distribution

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

Date initiated

2026-02-16

Date posted

2026-04-01

Location

Northfield, IL