FDA Devices recall · Reported October 15, 2014
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.
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 biocom…
Richard Wolf Medical Instruments Corp. recalled The Hulka Clip is a sterile packaged medical device that carries a two year expiration da… - a moderate-severity action.
The Hulka Clip is a sterile packaged medical device that carries a two year expiration da… was recalled by Richard Wolf Medical Instruments Corp. in October 15, 2014. Reason: Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The …. Check the official notice for the remedy. Verify recall #Z-0037-2015 with the FDA Devices before acting.
The recall
Richard Wolf Medical Instruments Corp. issued this moderate-severity FDA Devices recall-Richard Wolf Medical Instrument Corporation is recalling Hulka Clip Tubal Occluding Device lot 51000232. The ….
- Moderate
- severity level
- Class II
- classification
- October 15, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0037-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0037-2015 |
| Date reported | October 15, 2014 |
| Date initiated | July 9, 2014 |
| Recalling firm | Richard Wolf Medical Instruments Corp. |
| Firm location | Vernon Hills, IL |
| Affected scope | 73 cartons (1,460 clips) |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0037-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026