American Medical Systems Innovation Center - Silicon Valley
Complete recall history across all FDA and CPSC categories — 32 total recalls
American Medical Systems Innovation Center - Silicon Valley appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (32)
FDA medical device enforcement actions by American Medical Systems Innovation Center - Silicon Valley
| Date | Product | Reason | Class |
|---|---|---|---|
| May 28, 2015 | Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable to... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are inten... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | 200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool prov... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on Endo... | validation data related to cleaning instructions and sterilization methods an... | Class II |
| May 28, 2015 | Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool p... | validation data related to cleaning instructions and sterilization methods an... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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