Reusable distal attachments Models: MH-462 — Class II medical device recall Z-2523-2023
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-2523-2023 |
|---|---|
| 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 | 1,252 units |
| UPC / GTIN / UDI-DI | 04953170047732, 04953170047756, 04953170047770, 04953170047794, 04953170047817, 04953170047855, 04953170047893, 04953170047930, 04953170047978, 04953170047992, 04953170048012, 04953170048050, 04953170364518 |
| Model numbers | 4953170047732, 4953170047756, 4953170047770, 4953170047794, 4953170047817, 4953170047855, 4953170047893, 4953170047930, 4953170047978, 4953170047992, 4953170048012, 4953170048050, 4953170364518, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665 and 19 more |
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
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-2523-2023. 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.