Recall Z-2522-2023— Aomori Olympus Co., Ltd.

Name: FDA recall Z-2522-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-27

Class II · Ongoing

Class II FDA medical device recall by Aomori Olympus Co., Ltd., initiated 2023-07-27. It names one FDA 510(k) clearance: K984358. 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. Reason: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002.

Recalling firm: Aomori Olympus Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-27
Firm location: Kuroishi, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K984358 — OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597Olympus America, Inc.·cleared 1999-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.