Recall Z-1709-2026 ยท OGR Ear, Nose, And Throat Surgical Tray
Medline Industries, LP
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A
| Date | Apr 1, 2026 (initiated Feb 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.