Brand
Aomori Olympus Co., Ltd.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Aomori Olympus Co., Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-09-13FDA-DeviceClass IIReusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
- 2023-09-13FDA-DeviceClass IIOlympus 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
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
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