The Recall Desk
HighFDA (Devices)·Z-1708-2026·Announced 2026-04-08

Medline endoscopy kits contain recalled Olympus biopsy valves shedding fragments

Medline is recalling BAL and ENDO kits because they contain recalled Olympus biopsy valves, where rubber fragments may detach from the valve slit during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: fragments may lodge in a patient's airway and require removal, and no injuries are stated in the source.

Plain-English summary

Medline Industries, LP is recalling Medline kits containing Olympus biopsy valves, covering the BAL Kit (DYNDA2137B) and ENDO Kit (DYKE1915). About 14,379 kits were distributed across thirteen US states. The FDA has classified this recall as Class II.

The 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 of fragment detachment include a foreign body in the patient's tracheobronchial tree, which may require intervention for removal, along with inflammatory response, hypoxia and prolongation of the procedure.

Affected product carries UDI-DI 10195327501259 for the BAL Kit and 10195327371029 for the ENDO Kit, across the lot numbers listed in the FDA enforcement record.

Facilities can identify affected kits by the SKU, UDI and lot numbers above, and may contact Medline Industries, LP for further information.

The recalled product

Product
Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Manufacturer
Medline Industries, LP
Category
Medical Device — Endoscopy
Hazard
  • fragment-detachment
  • foreign-body-risk
  • airway-risk

Distribution

Distributed nationwide across the United States.

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