Northgate Technologies, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1885-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 10, 2020

Date Posted: May 13, 2020

Recall Number: Z-1885-2020

Event ID: 85204

Reason for Recall:

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

Status: Terminated

Product Quantity: 1238 boxes. 3 units per box.

Code Information:

NTI Catalog Number 72-00198-0.

Distribution Pattern:

US Nationwide distribution. No governmental.

Voluntary or Mandated:

Voluntary: Firm initiated