CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0… recallZ-0484-2015 · CooperSurgical, Inc. · initiated Oct 27, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0484-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 27, 2014
- Posted by the FDA
- Dec 2, 2014
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 595 units
- Product code
- HGI
- FDA submissions
- K905747
- Distribution
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
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.
Code information (models, lots, serial numbers)
Lot 159621 Exp Date: 2017-05
Other devices under the same FDA submission
1 device cleared under K905747 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LEEP Ball Electrode B0512Coopersurgical, Inc. · Electrocautery, Gynecologic (And Accessories)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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