CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
Stripper Disposable EndoStat Fiber recalled by American Medical Systems
American Medical Systems Innovation Center - Silicon Valley is recalling Stripper Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping, distributed nationwide in the US. The recall was initiated on 28 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2184-2015
- FDA event ID
- 71534
- Recalling firm
- American Medical Systems Innovation Center - Silicon Valley, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2015
- FDA classified
- 21 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 28 May 2015 | Recall initiated by company | |
| 21 Jul 2015 | Classified by FDA | +54 days |
| 29 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
Where it was distributed
Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
Questions about this recall
Why was it recalled?
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Which lots are affected?
Model 0010-0751; All product manufactured from April 8, 2012 to April 8, 2015
Where was it sold?
Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
31 other products · FDA event 71534This product is part of a recall event; the main page for the event is Tool, Stripper W/BLD, 18S, Nonautoclavable recalled.
More recalls from American Medical Systems Innovation Center - Silicon Valley
All 32| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stripper Disposable EndoStat Fiber recalled by American Medical Systems | American Medical Systems Innovation Center - Silicon Valley | Sterility | Nationwide |
| Device | CLASS II | Sureflex 150 Lithotripsy Fiber, 5x, Blue recalled | American Medical Systems Innovation Center - Silicon Valley | Sterility | Nationwide |
| Device | CLASS II | Sureflex 365 Lithotripsy Fiber, 5x, Blue recalled | American Medical Systems Innovation Center - Silicon Valley | Sterility | Nationwide |
| Device | CLASS II | Sureflex 200 Lithotripsy Fiber, 5x, Blue recalled | American Medical Systems Innovation Center - Silicon Valley | Sterility | Nationwide |
| Device | CLASS II | Fiber Stripper, 200¿m, Autoclavable recalled | American Medical Systems Innovation Center - Silicon Valley | Sterility | Nationwide |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |