Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Hulka Clip is a sterile packaged medical device that Recalled by Richard Wolf Medical Instruments Corp. Due to Richard Wolf Medical Instrument Corporation is recalling Hulka...
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 Richard Wolf Medical Instruments Corp. directly.
Affected Products
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.
Quantity: 73 cartons (1,460 clips)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Richard Wolf Medical Instruments Corp.
Richard Wolf Medical Instruments Corp. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report