Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 8, 2017
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, per…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Olympus Corporation of the Americas recalled URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope - a moderate-severity action.
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope was recalled by Olympus Corporation of the Americas in March 8, 2017. Reason: Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identi…. Check the official notice for the remedy. Verify recall #Z-1251-2017 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identi….
- Moderate
- severity level
- Class II
- classification
- March 8, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1251-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1251-2017) was formally reported on March 8, 2017, with the manufacturer initiating the action on December 12, 2016. 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 3461 units distributed to US consignees.
The documented reason for this recall is: Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were … Distribution data in the federal record shows the product reached: Distributed Nationwide. 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.
Medical Devices recalls over time
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.
Affected scope
3461 units distributed to US consignees
Related Recalls
6
3 from same agency
Product description
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Reason for recall
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1251-2017 |
| Date reported | March 8, 2017 |
| Date initiated | December 12, 2016 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 3461 units distributed to US consignees |
| Distribution | Distributed Nationwide |
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-1251-2017) 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? ▼
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope. Recalled by Olympus Corporation of the Americas. Units affected: 3461 units distributed to US consignees.
Why was this product recalled? ▼
Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1251-2017.
Where was the recalled product distributed? ▼
Distribution: Distributed Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1251-2017) 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 March 8, 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.