Olympus Recalls TJF-Q190V Duodenoscopes Due to Reported Mucosal Injury
Olympus is recalling 1,564 TJF-Q190V duodenoscopes and accessories worldwide due to complaints of mucosal injury associated with the forceps elevator region.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported mucosal injury, which constitutes a risk of harm where injury has been reported but no fatalities or severe systemic injuries are explicitly detailed in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,564 units of the TJF-Q190V duodenoscope and associated accessories, including the distal cover (model MAJ-2315). The recall covers 627 devices distributed domestically and 937 devices distributed internationally.
The recall was initiated after Olympus Medical Systems Corporation received complaints regarding mucosal injury associated with the forceps elevator region of the device. These instruments are used with Olympus video systems and ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
The affected devices were distributed worldwide, including nationwide in the United States and in countries such as Japan, Australia, and across Europe. Consumers and healthcare facilities should stop using the affected devices and contact Olympus for further instructions.
The recalled product
- Product
- Duodenoscope and accessories, flexible/rigid - Product Usage: used 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…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: TJF-Q190V
Distribution
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