Z-1884-2020Class II

AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 -

Name: Z-1884-2020 AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 -
Creator: Northgate Technologies, Inc.
Published: 2020-03-10
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2020-03-10 / Terminated / root cause: manufacturing process

FDA source

Northgate Technologies, Inc. began a recall of 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 on 2020-03-10. FDA classified it as Class II and gives the reason as "Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1884-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Posted: 2020-03-24
Terminated: 2021-02-02
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.
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Root cause tag: manufacturing process
FDA 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 in commerce: 198 boxes. 3 units per box.
Distribution: US Nationwide distribution. No governmental.
Product codes and lots: NTI Catalog Number 9-203-0543.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1884-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1883-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1884-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04
Z-1885-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-04

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)