Medline kits containing Olympus biopsy valves recallZ-1708-2026 · Medline Industries, LP · initiated Feb 16, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1708-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 16, 2026
- Posted by the FDA
- Apr 1, 2026
- Recalling firm
- Medline Industries, LP
- Quantity
- 14,379 kits total
- Product code
- OFF
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Product description
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Code information (models, lots, serial numbers)
1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYKE1915Medline Industries, Inc. · Central venous catheter tray1 recall0 reports
- Medline Industries, Inc. DYNDA2137BMedline Industries, Inc. · Central venous catheter tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98530).
- Z-1705-2026 · Open, ClassifiedAirway Exam Kit, DYKE1796
- Z-1706-2026 · Open, ClassifiedMedline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A
- Z-1707-2026 · Open, ClassifiedTHORACIC ROBOTS, DYNJ908777B
- Z-1709-2026 · Open, ClassifiedMedline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ…
- Z-1710-2026 · Open, ClassifiedMedline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0…
- Z-1711-2026 · Open, ClassifiedMEDLINE ANTERIOR HIP PACK DYNJ64672B
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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