E-Line Cutting Electrode 11 — Class II medical device recall Z-1957-2019
Terminated recall by Richard Wolf Medical Instruments Corp., reported 2019-07-17, distributed nationwide. E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting El
| Recall number | Z-1957-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf Medical Instruments Corp., Vernon Hills, IL, United States |
| Recall initiated | 2019-05-23 |
| Classified | 2019-07-10 |
| Reported by FDA | 2019-07-17 |
| Terminated | 2020-08-04 |
| Distributed | Nationwide (US) |
| Lot numbers | 1390827 |
| Expiration dates | 2023-10-15 |
Product
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.
Reason for recall
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
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-1957-2019. 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.