Z-1847-2021Class II

CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP...

Name: Z-1847-2021 CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP...
Creator: CooperSurgical, Inc.
Published: 2021-04-30
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2021-04-30 / Terminated / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures... on 2021-04-30. FDA classified it as Class II and gives the reason as "The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode". 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-1847-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-30
Posted: 2021-06-10
Terminated: 2023-07-21
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 30, 2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Rounded Electrodes were sealed in packaging labeled as a Square Electrodes. Customers were provided the following instructions: Please inspect stock, quarantine, and discontinue use of all products subject to this recall, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacement(s) and return of affected Product(s). The replacement Product(s) will be charged at the same price as the original order and your account will be credited back once the affected Product(s) are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Recall Notice.
Quantity in commerce: 20 boxes of 5 each
Distribution: US distribution to: CA, MD, MO, NJ, PA, and TX
Product codes and lots: Lot 274420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1847-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1847-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-10

Product code GEI

K020711Class IIWallach Loop ElectrodeWallach Surgical Devices, Inc. / cleared 2002-06-03

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)