FDA Device recall Z-1957-2019
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile
- FDA Device
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile by Richard Wolf Medical Instruments, citing E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1957-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-23 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Richard Wolf Medical Instruments |
| Distribution | US |
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
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Identifiers
| code_info | Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1957-2019%22
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