Device evidence

device-recall:cfres:214144

Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

Official recall number

Z-2139-2025

Evidence summary

Product code: HIH
Recall status: Open, Classified
Event initiated: June 18, 2025
Root cause: Packaging change control
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2139-2025