FDA Device recall Z-1847-2021
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131 by Coopersurgical, citing the affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1847-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-30 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | CA, MD, MO, NJ, PA, TX |
Product
CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genital tract
Reason
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
Identifiers
| code_info | Lot 274420 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1847-2021%22
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