Olympus Distal Attachment — Class II medical device recall Z-2522-2023
Ongoing recall by Aomori Olympus Co., Ltd., reported 2023-09-13, distributed nationwide. The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level c
| Recall number | Z-2522-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aomori Olympus Co., Ltd., Kuroishi, N/A, Japan |
| Recall initiated | 2023-07-27 |
| Classified | 2023-09-07 |
| Reported by FDA | 2023-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,048 units |
| UPC / GTIN / UDI-DI | 04953170048562, 04953170048579, 04953170048586, 04953170048593, 04953170214035, 04953170214042 |
| Lot numbers | 0XI, 0YI, 12I, 13I, 14I, 15I, 16I, 17I, 25K, 26K, 27K, 28K, 29K, 2XK, 2YK, 2ZK, 31K, 32K, 5835330, 5835430, 5835530, 5835630, K-003, N2485230, N2485330 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2522-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.