Aomori Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2523-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Reusable 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

Product Classification:

Class II

Date Initiated: July 27, 2023

Date Posted: September 13, 2023

Recall Number: Z-2523-2023

Event ID: 92784

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

Status: Ongoing

Product Quantity: 1,252 units

Code Information:

Model: UDI: MH-462 4953170047732 MH-463 4953170047756 MH-464 4953170047770 MH-465 4953170047794 MH-466 4953170047817 MH-483 N/A MH-587 4953170047855 MH-588 4953170364518 (US) MH-589 4953170047893 MH-590 N/A MH-591 4953170047930 MH-592 N/A MH-593 4953170047978 MH-594 4953170047992 MH-595 4953170048012 MH-596 N/A MH-597 4953170048050 MH-598 N/A MAJ-289 N/A MAJ-290 N/A MAJ-291 N/A MAJ-292 N/A MAJ-293 N/A MAJ-294 N/A MAJ-295 N/A MAJ-296 N/A MAJ-297 N/A MAJ-663 N/A MAJ-664 N/A MAJ-665 N/A MAJ-666 N/A DIstal Attachment- All lots

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated