FDA Device recall 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): R2010 Intended Use: Diagnosis an…
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II 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 an… by Coopersurgical, citing outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0484-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-27 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coopersurgical |
| Distribution | US |
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
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Identifiers
| code_info | Lot 159621 Exp Date: 2017-05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0484-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.