medical Class II Updated 2020-05-13

Northgate Technologies, Inc. recalls ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Tec

Recalled Product

ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.


Hazard / Issue

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NTI Catalog Number 72-00198-0.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →