The Hulka Clip is a sterile packaged medical device that… recallZ-0037-2015 · Richard Wolf Medical Instruments Corp. · initiated Jul 9, 2014
Class II Terminated All recalls posted in November 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Richard Wolf Medical Instruments Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
"Urgent: Medical Device Recall" letters dated July 9, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to: 1) inspect their inventories for the recalled products; 2) contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380 to notify Richard Wolf Medical Instruments if you have any devices in inventory; 3) review your records and report the number, if any, of Hulka Clips from lot 51000232 that were implanted in your patients on the Recall Response Form; 4) complete and return the Recall Response Form attached to the letter; and, 5) a RMA number will be provided to customers returning the recalled products and those customers will receive a credit. All returned product should be sent to the attention of Ms. Lisa Williams, Regulatory Specialist. Customers with questions can contact Richard Wolf Medical Instruments at 800-323-9653 x 225 or 380.
Recall details
- Recall number
- Z-0037-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 9, 2014
- Posted by the FDA
- Nov 6, 2014
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Quantity
- 73 cartons (1,460 clips)
- Product code
- KNH
- FDA submissions
- P870080
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
Product Code: 4986.09; Lot: 51000232
Other devices under the same FDA submission
1 device cleared under P870080 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hulka Clips 4986.90Richard Wolf Medical Instruments Corp. · Device, Occlusion, Tubal, Contraceptive3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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