15 g R — Class II medical device recall Z-0086-2017
Terminated recall by Epimed International, Inc., reported 2016-11-09, distributed in AK, AL, FL, IN, TN, TX. There is a possibility that the needles may have the potential to skive a catheters outer coating. If this we
| Recall number | Z-0086-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epimed International, Inc., Johnstown, NY, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2016-10-31 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2018-06-14 |
| Distributed | AK, AL, FL, IN, TN, TX |
| Quantity | 576 units |
| Lot numbers | 12157181, 12157325, 12157445, 2801501, 3161501, 3211503, GC091702, GC101871, GC101897 |
| Model numbers | 100-1415 |
Product
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Reason for recall
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
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-0086-2017. 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.