Aomori Olympus Co., Ltd. recalls Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.…

Recall date

July 27, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2522-2023

FDA classification

Class II

Brand / firm

Aomori Olympus Co., Ltd.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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