RX-2 COUDE Epidural Needle — Class II medical device recall Z-0087-2018
Terminated recall by Epimed International, reported 2017-11-15, distributed in AR, CA, IA, IN, KY, LA, MI, NY…. Potential for partially incomplete seal of product, impacting sterility.
| Recall number | Z-0087-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epimed International, Farmers Branch, TX, United States |
| Recall initiated | 2017-07-24 |
| Classified | 2017-11-09 |
| Reported by FDA | 2017-11-15 |
| Terminated | 2023-07-06 |
| Distributed | AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, WA |
| Countries outside the US | CA, CZ, DE, TR |
| Quantity | 500 units |
| Reason classes | sterility, packaging |
| Lot numbers | 12168200 |
| Model numbers | 107-1416 |
Product
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Reason for recall
Potential for partially incomplete seal of product, impacting sterility.
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-0087-2018. 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.