CooperSurgical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0484-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 27, 2014

Date Posted: December 3, 2014

Recall Number: Z-0484-2015

Event ID: 69636

Reason for Recall:

Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode

Status: Terminated

Product Quantity: 595 units

Code Information:

Lot 159621 Exp Date: 2017-05

Distribution Pattern:

Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated