Olympus recalls transnasal esophagovideoscopes with model PEF-V that may have water contamination in the channel, posing infection risks. Affected units sold in the U.S. from 2020-2021.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Olympus is recalling transnasal esophagovideoscopes with model number PEF-V due to potential water contamination in the channel that could lead to infections. This recall affects medical devices used for endoscopic procedures in the esophagus and stomach.
The channel air drying process wasn't properly validated, so some scopes returned after repair had water remaining. This water could contaminate the device and lead to infections if used improperly.
Healthcare professionals using the Olympus transnasal esophagovideoscopes for endoscopic procedures are most at risk. Patients undergoing these procedures with affected devices could potentially face infection risks.
Check for model number PEF-V on the device. Affected units were sold in the U.S. between 2020 and 2:2021.
Look for model number PEF-V on the device label or packaging.
The recall is for potential infection risk from water contamination in the channel, but the risk is low as only a small percentage of scopes had water remaining after repair.
Check for model number PEF-V on the device. Affected units were sold in the U.S. between 2020 and 2021.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0344-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0344-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
