Reported Mar 31, 2021 · Terminated
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source,…
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?
- Duodenoscope and accessories
- flexible/rigid - Product Usageused with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum
- Lot codes and dates
- ModelTJF-Q190V
- Amount recalled
- 1564 devices total (Domestic: 627 devices, Foreign: 937 devices)
Where it was sold
Why it was recalled
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
This product could cause temporary or reversible health problems — stop using it.
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