Richard Wolf Hulka Clip recallZ-0272-2010 · Richard Wolf Medical Instruments Corp. · initiated Oct 16, 2009
Terminated All recalls posted in November 2009
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
The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
FDA root cause category: Packaging
What the company is doing
Richard Wolfe sent recall letters dated October 16, 2009 to the direct accounts via certified mail on the same date. The accounts were informed that the lot of Hulka clips did not meet their sterile seal burst test requirements, and that the sterile seal may fail to remain intact during handling, resulting in the clips becoming contaminated or non-sterile. They were instructed to inspect their inventory for the affected lot, quarantine any product found and call Richard Wolf at 800-323-9653, ext 225 or 380 to arrange for the return of the affected product for replacement. The accounts were also requested to complete and return the enclosed response form to Richard Wolf, even if they do not have any of the affected lot in stock.
Recall details
- Recall number
- Z-0272-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 16, 2009
- Posted by the FDA
- Nov 17, 2009
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Quantity
- 150 cartons
- Product code
- HGB
- FDA submissions
- P870080
- Distribution
- Nationwide
Product description
Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes
Code information (models, lots, serial numbers)
lot number 1391, expiry date 02.2010
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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