FDA Recalls American Medical Systems Fiber Strippers for Validation Issues
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves validation data not meeting guidance for reusable products, which is a regulatory and quality control issue rather than a direct, reported injury or high-risk pathogen exposure, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the Stripper, 0.3mm Disposable EndoStat Fiber. The recall affects Model 0010-0754 manufactured between April 8, 2012, and April 8, 2015. These devices are distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet new FDA guidance on qualifying reusable products. The Fiber Stripper is a tool used to strip the protective jacket off the end of an Endostat or SureFlex Fiber and does not come into direct contact with the patient.
Healthcare facilities and distributors should stop using the affected devices and contact American Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- Stripper, 0.3mm 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, corresp
- Affected units
- 16,710
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model 0010-0754
- All product manufactured from April 8
- 2012 to April 8
- 2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by American Medical Systems Innovation Center - Silicon Valley under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 32 products in this recall →Related recalls
Same manufacturer · American Medical Systems Innovation Center - Silicon Valley
See all →- ModerateFDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighFDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Same hazard · validation deficiency
See all →- HighCardioplegia Solution Recalled Due to Inadequate Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighCardioplegia Solution Recalled Due to Sterility Assurance Deficiency
FDA (Drugs) · 2023-08-09
- HighBusse Pellet Insertion Tray Kits Recalled for Manufacturing Validation Issues
FDA (Devices) · 2022-06-08
- ModerateFDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighStryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies
FDA (Devices) · 2014-07-02