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

Recalled September 13, 2023 · FDA recall Z-2522-2023 · Aomori Olympus

Hazard

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

Units

1,048 units

Sold at

US Nationwide distribution.

Description

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

Product

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

Manufacturer(s)

Aomori Olympus Co., Ltd.

Made in

Japan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →