The Hulka Clip is a sterile packaged medical device that carries a… — Class II medical device recall Z-0037-2015
Terminated recall by Richard Wolf Medical Instruments Corp., reported 2014-10-15, distributed nationwide. Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The d
| Recall number | Z-0037-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf Medical Instruments Corp., Vernon Hills, IL, United States |
| Recall initiated | 2014-07-09 |
| Classified | 2014-10-07 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Lot numbers | 51000232 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0037-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.