PENTAX Ultrasound Endoscope Update: Why Water-Bottle Instructions Matter

Sometimes an important medical device recall doesn't involve removing equipment. It involves changing how the equipment is prepared and used.

That's the lesson behind a recent PENTAX Medical field safety notice affecting certain ultrasound endoscopes and their water-bottle assemblies.

What Happened?

In September 2026, PENTAX Medical initiated a correction involving several ultrasound endoscope models and the OS-H5 water-bottle assembly.

The FDA posted Class II recall records on October 28.

The manufacturer updated the instructions for use to reinforce the importance of having deaerated sterile water in the water-bottle assembly before and during procedures.

The affected products include several ultrasound endoscope models, including EG38-J10UT, EG34-J10U, EG36-J10UR, and EG-3270UK, as well as the OS-H5 water-bottle assembly.

The FDA records identify all serial numbers of the listed models.

What Changed?

According to the FDA, PENTAX instructed customers to update their instructions for use and inform relevant staff.

The notice also included preparation guidance.

Customers were instructed to change the water for each procedure and fill the bottle approximately two-thirds full, or to the 200 marking, with sterile water.

If the water or balloon-feeding function does not work, the manufacturer's instructions specify filling the bottle with deaerated sterile water.

Facilities should consult the complete updated instructions rather than relying on a summary of the notice.

Why It Matters to Surgical Professionals

Endoscopic ultrasound combines imaging technology with specialized equipment preparation.

And in a busy procedural environment, smaller accessories can receive less attention than the primary device.

But an endoscope doesn't operate independently of its supporting components.

Water-bottle assemblies, connections, and preparation processes contribute to the overall system.

This correction highlights the importance of understanding the manufacturer's current instructions—not simply relying on how equipment has traditionally been prepared.

It also raises a practical training question:

When an instruction manual changes, how do we make sure the people using the equipment actually know?

The FTLOS Takeaway

Equipment competency isn't a one-time achievement.

Instructions can change.

Manufacturers can identify new concerns.

And facilities must have a reliable way to communicate those updates to frontline professionals.

Sometimes, improving safety begins with something as straightforward as making sure everyone is working from the same instructions.

Join the Conversation

How does your department communicate updates to equipment instructions for use?

U.S. Food and Drug Administration. “Class 2 Device Recall PENTAX Medical Ultrasound Endoscope.” FDA Medical Device Recalls, 28 Oct. 2026, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=223088.

U.S. Food and Drug Administration. “Class 2 Device Recall PENTAX Medical Water Bottle Assembly.” FDA Medical Device Recalls, 28 Oct. 2026, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=223091.