Z-2537-2017Class II

Clarke-Reich Laparoscopic Knot Pusher

Name: Z-2537-2017 Clarke-Reich Laparoscopic Knot Pusher
Creator: Cook Inc.
Published: 2017-04-25
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-04-25 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Clarke-Reich Laparoscopic Knot Pusher on 2017-04-25. FDA classified it as Class II and gives the reason as "reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products". 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-2537-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2017-06-14
Terminated: 2019-03-26
Recalling firm: Cook Incorporated
Product: Clarke-Reich Laparoscopic Knot Pusher
Product code: NWV Laparoscopic Accessories, Gynecologic
Reason for recall: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Quantity in commerce: 178
Distribution: The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Product codes and lots: All lots Catalog numbers: J-CRKP-042900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2537-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2534-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2535-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2536-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2537-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2538-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code NWV

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)