CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131 — Class II medical device recall Z-1847-2021
Terminated recall by CooperSurgical, Inc., reported 2021-06-16, distributed in CA, MD, MO, NJ, PA, TX. The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled
| Recall number | Z-1847-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2021-04-30 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-07-21 |
| Distributed | CA, MD, MO, NJ, PA, TX |
| Reason classes | labeling |
| Lot numbers | 274420 |
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 for recall
The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square 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-1847-2021. 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.