Asahi KASEI — Class II medical device recall Z-2423-2012
Terminated recall by Asahi Kasei Medical Co., Ltd., Okatomi Plant, reported 2012-09-26, distributed in TN. Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufactur
| Recall number | Z-2423-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Asahi Kasei Medical Co., Ltd., Okatomi Plant, Nobeoka-shi, Japan |
| Recall initiated | 2012-09-21 |
| Classified | 2012-09-20 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-02-05 |
| Distributed | TN |
| Countries outside the US | DE, JP |
| Quantity | 24 units |
| Lot numbers | 296T78 |
Product
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
Reason for recall
Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
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-2423-2012. 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.