Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I
FDA device recall Z-1710-2026 · 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
- LRO
- 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline General Surgery Tray (K213481) | Medline Industries, Inc. | 2022-05-24 |