Z-0484-2015Class II

CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s)...

Name: Z-0484-2015 CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s)...
Creator: CooperSurgical, Inc.
Published: 2014-10-27
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2014-10-27 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of... on 2014-10-27. FDA classified it as Class II and gives the reason as "Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0484-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Posted: 2014-12-02
Terminated: 2015-05-29
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Product code: HGI Electrocautery, Gynecologic (And Accessories)
Reason for recall: Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Root cause tag: packaging
FDA root cause: Packaging process control
Action: CooperSurgical issued recall letter dated October 27, 2014, to all affected customers via certified mail delivery (UPS). Acccounts were requested to return product for replacement and complete the return response form. Customers with questions were instructed to call 203-601-5200.
Quantity in commerce: 595 units
Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
Product codes and lots: Lot 159621 Exp Date: 2017-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0484-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0484-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-27

Product code HGI

K905747Class IILeep System 6000 Electrosurgical Unit and AccessorCoopervision Surgical / cleared 1991-09-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)