Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. Recalled by Aizu Olympus Co., Ltd. Due to Channel air drying process was not validated, and...

Date: September 25, 2023
Company: Aizu Olympus Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aizu Olympus Co., Ltd. directly.

Affected Products

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

Quantity: 16 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aizu Olympus Co., Ltd.

Aizu Olympus Co., Ltd. has 31 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report