FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: 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.
- Recall number
- Z-0484-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-10-27
- Posted
- 2014-12-02
- Terminated
- 2015-05-29
- Reason
- Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
- 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
- 595 units
- Distribution
- Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
- Lot, serial or model codes
- Lot 159621 Exp Date: 2017-05
- 510(k) numbers
- ["K905747"]
- PMA numbers
- not on file
- Product code
- HGI
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28