PlainRecalls

American Medical Systems Innovation Center - Silicon Valley

Compiled from official public sources by the editorial team.

32 recalls on record · Latest: Jul 29, 2015

American Medical Systems Innovation Center - Silicon Valley Recall Insight

American Medical Systems Innovation Center - Silicon Valley appears on 32 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.031% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 29, 2015, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 32 entries, severity tagging shows 0 critical, 32 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 32 of 32 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (32). The date window on this page runs from Jul 29, 2015 to Jul 29, 2015.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizabl…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 550¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to…

FDA Devices Moderate Jul 29, 2015

Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The t…

FDA Devices Moderate Jul 29, 2015

Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or S…

FDA Devices Moderate Jul 29, 2015

Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

FDA Devices Moderate Jul 29, 2015

Fiber Stripper, 200¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureF…

FDA Devices Moderate Jul 29, 2015

Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not lim…

FDA Devices Moderate Jul 29, 2015

Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat o…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare American Medical Systems Innovation Center - Silicon Valley with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.