# FDA recall Z-2522-2023

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

## 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 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-2522-2023
- **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-2522-2023

## Citation

> AI Analytics. FDA recall Z-2522-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2522-2023. Source: US FDA. Licensed CC0.

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