Z-1840-2019Class II

LEEP Precision Integrated System 120V, Model LP-10-120

Name: Z-1840-2019 LEEP Precision Integrated System 120V, Model LP-10-120
Creator: CooperSurgical, Inc.
Published: 2019-04-23
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2019-04-23 / Terminated / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION... on 2019-04-23. FDA classified it as Class II and gives the reason as "2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses". 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-1840-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-23
Posted: 2019-06-19
Terminated: 2020-04-24
Recalling firm: CooperSurgical, Inc.
Product: LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
Product code: HGI Electrocautery, Gynecologic (And Accessories)
Reason for recall: 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 23, 2019, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to immediately discontinue use of the discrepant product, quarantine the product, and replace the 2 main fuses with the 2 fuses provided with the firm's mailing. Customers were provided with instructions to replace the fuses. Once customers have successfully completed the fuse replacement, they are asked to complete the Acknowledgement and Receipt form and return it to CooperSurgical. If you have any questions, please contact the firm at 203-601-5200 ext. 3300.
Quantity in commerce: 19
Distribution: US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.
Product codes and lots: 2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,2018110013, 2018110014, 2018110015,2018110016, 2018110017, 2018110019, 2018110020,2018110021,& 2018110022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1840-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1840-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-18

Product code HGI

K963348Class IIWallach Integration UnitWallach Surgical Devices, Inc. / cleared 1997-03-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)