Severity
Moderate
FDA Devices recall · Reported July 5, 2017
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Olympus Corporation of the Americas recalled High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrode… - a moderate-severity action.
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrode… was recalled by Olympus Corporation of the Americas in July 5, 2017. Reason: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.. Check the official notice for the remedy. Verify recall #Z-2629-2017 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2629-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2629-2017) was formally reported on July 5, 2017, with the manufacturer initiating the action on April 19, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 1264 units.
The documented reason for this recall is: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. Distribution data in the federal record shows the product reached: Nationwide Distribution. 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, 3 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.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Severity
Moderate
Affected scope
1264 units
Related Recalls
6
3 from same agency
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2629-2017 |
| Date reported | July 5, 2017 |
| Date initiated | April 19, 2017 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 1264 units |
| Distribution | Nationwide Distribution |
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.
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.
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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 5, 2017. 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 July 2026.