Reported Mar 8, 2017 · Terminated
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-0610
Is this the product you have?
- Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
- Lot codes and dates
- All serial numbers
- Amount recalled
- 1,627 units (769 URF-V2 and 858 URF-V2R)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Olympus Corporation of the Americas recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.