Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

15 g R.K. Epidural Needle (TW) Recalled by Epimed International, Inc. Due to There is a possibility that the needles may...

Date: April 22, 2016
Company: Epimed International, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Epimed International, Inc. directly.

Affected Products

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

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 6 states: AL, AK, FL, IN, TN, TX

Affected (6 states)Not affected

About Epimed International, Inc.

Epimed International, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report