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Recall Observatory FDA recall evidence

Device product

MEDLINE ANTERIOR HIP PACK DYNJ64672B

Z-1711-2026

February 16, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98530
Status
Ongoing
Classification
Class II
Quantity
14,379 kits total
Official record key
device-enforcement:Z-1711-2026

Official wording

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.

Code information: UDI-DI 10195327377496 (EA) 40195327377497 (CS) LOT 23LMD300

Distribution pattern: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign body