# FDA recall Z-2523-2023

> **Aomori Olympus Co., Ltd.** · Class II · device recall initiated 2023-07-27.

## Product

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

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2523-2023
- **Recalling firm:** Aomori Olympus Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-27
- **Report date:** 2023-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kuroishi, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2023

## Citation

> AI Analytics. FDA recall Z-2523-2023. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2523-2023. Source: US FDA. Licensed CC0.

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