NEO-KATH Epidural Catheter Set — Class II medical device recall Z-2312-2021
Completed recall by Epimed International, reported 2021-08-25, distributed in CA, DE, OH, OK, PA, VA, WA, WV. Potential for stylet to protrude from the distal end of the catheter
| Recall number | Z-2312-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epimed International, Farmers Branch, TX, United States |
| Recall initiated | 2017-12-28 |
| Classified | 2021-08-18 |
| Reported by FDA | 2021-08-25 |
| Distributed | CA, DE, OH, OK, PA, VA, WA, WV |
| Countries outside the US | CA, IR |
| Quantity | 132 units |
| Lot numbers | 16308275 |
| Model numbers | 200-2430 |
| Expiration dates | 2022-08-20, 2022-10-20 |
Product
NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile
Reason for recall
Potential for stylet to protrude from the distal end of the catheter
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-2312-2021. 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.