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FDAJuly 27, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

aomori olympusaomori

UPCs

495317004856249531700485794953170048586495317004859349531702140354953170214042

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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