Z-1235-2022Class II

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

Name: Z-1235-2022 AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Creator: Northgate Technologies, Inc.
Published: 2022-04-13
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2022-04-13 / Terminated / root cause: labeling and UDI

FDA source

Northgate Technologies, Inc. began a recall of AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe on 2022-04-13. FDA classified it as Class II and gives the reason as "Product labeled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1235-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-13
Posted: 2022-06-03
Terminated: 2022-11-08
Recalling firm: Northgate Technologies Inc.
Product: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Product labeled incorrectly.
Root cause tag: labeling and UDI
FDA 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 in commerce: 55 probes
Distribution: US Nationwide distribution in the state of MA.
Product codes and lots: NTI Catalog Number 72-00322-0 / BSC Catalog No. M00546620; Lot code: BSC15876; GTIN: 00817183020448.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-15	2022-06-03

Product code FFK

K130368Class IIAutolith Touch; Uro TouchNorthgate Technologies, Inc. / cleared 2013-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)