CooperSurgical LEEP RADIUS LOOP ELECTRODE — Class II medical device recall Z-0484-2015
Terminated recall by CooperSurgical, Inc., reported 2014-12-03, distributed nationwide. Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Ele
| Recall number | Z-0484-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2014-10-27 |
| Classified | 2014-11-27 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, PT |
| Quantity | 595 units |
| Reason classes | labeling |
| Lot numbers | 159621, 2017-05 |
| Model numbers | R2010 |
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.
Reason for recall
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0484-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.