Epimed International, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0086-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 22, 2016

Date Posted: November 9, 2016

Recall Number: Z-0086-2017

Event ID: 74018

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.

Status: Terminated

Product Quantity: 576 units

Code Information:

1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)

Distribution Pattern:

US Distribution to the states of : AL, AK, FL, IN, TN & TX

Voluntary or Mandated:

Voluntary: Firm initiated