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Open, Classified

THORACIC ROBOTS, DYNJ908777B

FDA Recall Z-1707-2026 · Posted 2026-04-01

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2026-02-16
Product Quantity14,379 kits total

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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