The Recall Desk
SevereFDA (Devices)·Z-2467-2023·Announced 2023-09-06

EVIS EXERA III Duodenovideoscope Recalled Due to Patient Infection Reports

Olympus Corporation recalls 6,426 units of the EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to recent reports of patient infections. The device was distributed nationwide in the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II medical device with reported patient infections, which constitute significant injury reports warranting immediate action.

Plain-English summary

The Olympus Corporation of the Americas is recalling 6,426 units of the EVIS EXERA III Duodenovideoscope, Model TJF-Q190V, due to recent reports of patient infections associated with the device. The device was distributed nationwide in the United States.

The recalled units are identified by Model No. TJF-Q190V and UDI-DI 04953170405563. Healthcare providers and facilities that use this device should contact Olympus Corporation of the Americas for recall instructions.

Patients who have undergone procedures using this device should consult their healthcare provider if they have concerns about a potential infection. Any patient experiencing symptoms of infection following a procedure using this device should seek immediate medical attention.

The recalled product

Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope
Hazard
  • infection

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 (3)

  • Model No. TJF-Q190V
  • UDI-DI: 04953170405563
  • All Serial No.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category