Northgate Technologies, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Northgate Technologies, Inc.
Lot Codes / Batch Numbers
NTI Catalog Number 72-00198-0.
Products Sold
NTI Catalog Number 72-00198-0.
Northgate Technologies, Inc. is recalling ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog N due to Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Recommended Action
Per FDA guidance
Northgate Technologies, Inc. notified customers on 03/11/2020 via "Urgent: medical Device Recall Notification" email. The recall notice identified the affected and requested the customers to cease distribution and destroy affected product. The customers were asked to complete the "Recall Acknowledgment Form".
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026