FDA Medical Device Recalls (openFDA)
Northgate Technologies, Inc.: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
- Recall number
- Z-1235-2022
- Recalling firm
- Northgate Technologies, Inc.
- Product
- AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
- Status
- Terminated
- Initiated
- 2022-04-13
- Posted
- not on file
- Terminated
- 2022-11-08
- Reason
- Product labeled incorrectly.
- Root cause
- Under Investigation by firm
- Action
- The firm sent out the recall notification to their consignee on 04/13/2022 via email. The firm sent out a letter as well on 04/27/2022 which instructs the consignee to cease distribution, quarantine affected units and return affected product. If the distributor further distributed the product, they are asked to notify their customers.
- Quantity
- 55 probes
- Distribution
- US Nationwide distribution in the state of MA.
- Lot, serial or model codes
- NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.
- 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