Richard Wolf Medical Instruments Corp.: Medical Device Recall in 2014 - (Recall #: Z-0037-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

The Hulka Clip is a sterile packaged medical device that carries a two year expiration date. It is packaged two clips per procedural tray. Theses procedural trays are then sealed in a Tyvek/Mylar pouch and packaged in a cardboard shipping carton with ten pouches in each shipping carton.

Product Classification:

Class II

Date Initiated: July 9, 2014

Date Posted: October 15, 2014

Recall Number: Z-0037-2015

Event ID: 68777

Reason for Recall:

Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The devices are being recalled as a part of an investigation into a biocompatibility test discrepancy where the recalled lot (lot 51000232) passed final release testing, but the subsequent lot failed biocompatibility testing on a component that was also used to manufacture lot 51000232.

Status: Terminated

Product Quantity: 73 cartons (1,460 clips)

Code Information:

Product Code: 4986.09; Lot: 51000232

Distribution Pattern:

Worldwide distribution: US (Nationwide) including states of: (AK, AL, CO, CT, FL, GA, IA, IN, KY, LA, MI, MO, MS, NC, NY, OH, OR, PA, SC, TN, TX, VA, WA, WV; and country of: Germany.

Voluntary or Mandated:

Voluntary: Firm initiated