FDA Medical devices recall ·
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2… recall
- Recall number
- Z-1708-2026
- Date
- (initiated February 16, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,379 kits total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
States: California Florida Illinois Indiana Kentucky Massachusetts Maryland Montana New York Ohio Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1708-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.