Class II — Potential Health Hazard

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

Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to Recalled by Aomori Olympus Co., Ltd. Due to The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which...

Date: July 27, 2023
Company: Aomori 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 Aomori Olympus Co., Ltd. directly.

Affected Products

Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012

Quantity: 1,048 units

Why Was This Recalled?

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aomori Olympus Co., Ltd.

Aomori Olympus Co., Ltd. has 113 total recalls tracked by RecallDetector.

Related Recalls

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