Class II — Epimed International, Inc.
| Recalling firm | Epimed International, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Quantity | 576 units |
| Distribution | US Distribution to the states of : AL, AK, FL, IN, TN & TX |
| Initiated | 2016-04-22 |
| Classified | 2016-10-31 |
| Terminated | 2018-06-14 |
| Recall number | Z-0086-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Epimed International, Inc. (Z-0086-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74018/
Alerts for Epimed International, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.