Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 17, 2019
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.
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Richard Wolf Medical Instruments Corp. recalled E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a pl… - a moderate-severity action.
E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a pl… was recalled by Richard Wolf Medical Instruments Corp. in July 17, 2019. Reason: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting E…. Check the official notice for the remedy. Verify recall #Z-1957-2019 with the FDA Devices before acting.
The recall
Richard Wolf Medical Instruments Corp. issued this moderate-severity FDA Devices recall-E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting E….
- Moderate
- severity level
- Class II
- classification
- July 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1957-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1957-2019) was formally reported on July 17, 2019, with the manufacturer initiating the action on May 23, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Richard Wolf Medical Instruments Corp. is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records list the affected scope as 5 boxes (5 electrodes each).
The documented reason for this recall is: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. Distribution data in the federal record shows the product reached: US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5 boxes (5 electrodes each)
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1957-2019 |
| Date reported | July 17, 2019 |
| Date initiated | May 23, 2019 |
| Recalling firm | Richard Wolf Medical Instruments Corp. |
| Firm location | Vernon Hills, IL |
| Affected scope | 5 boxes (5 electrodes each) |
| Distribution | US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1957-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Richard Wolf Medical Instruments Corp.. Units affected: 5 boxes (5 electrodes each).
Why was this product recalled? ▼
E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2019. Severity: Moderate. Recall number: Z-1957-2019.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1957-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 17, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.