FDA Medical Device Recalls (openFDA)
Northgate Technologies, Inc.: AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Recall number
- Z-1884-2020
- Recalling firm
- Northgate Technologies, Inc.
- Product
- AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
- Status
- Terminated
- Initiated
- 2020-03-10
- Posted
- 2020-03-24
- Terminated
- 2021-02-02
- Reason
- Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- Root cause
- Nonconforming Material/Component
- Action
- 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".
- Quantity
- 198 boxes. 3 units per box.
- Distribution
- US Nationwide distribution. No governmental.
- Lot, serial or model codes
- NTI Catalog Number 9-203-0543.
- 510(k) numbers
- ["K130368"]
- PMA numbers
- not on file
- Product code
- FFK
- Firm FEI
- 1450997
- Firm city
- Elgin
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28