Z-1711-2026 Class II Ongoing
FDA device recall Z-1711-2026 was initiated by Medline Industries, LP on February 16, 2026 and is designated Class II. 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 consequenc… The recall status is ongoing. Affected quantity: 14,379 kits total.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,379 kits total
Product Description
MEDLINE ANTERIOR HIP PACK DYNJ64672B
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
Code Information
UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300