PlainRecalls

American Medical Systems Innovation Center - Silicon Valley

Compiled from official public sources by the publisher.

32 recalls on record · Latest: Jul 29, 2015

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Agency notice ledger

Federal filing book American Medical Systems In… MID-BOOK · SINGLE-AGENCY

#521 of 14,151 · 32 notices · 0.031% archive

  • BOOK 32 notices
  • RANK #521 of 14,151
  • SHARE 0.031% archive
  • AGENCY FDA Devices (32)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 29, 2015
  • PHOTO Abbott Laboratories,…

Nearest notice-volume peer: Abbott Laboratories, Inc (0 notice gap)

American Medical Systems Innovation Center - Silicon Valley accounts for about 0.031% of the 104,423-notice archive on 32 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where American Medical Systems In… sits among 14,151 recalling firms

American Medical Systems Innovation Center - Silicon Valley ranks 521st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

American Medical Systems In… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

32 521st of 14151 higher than 13,619 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

American Medical Systems In… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows American Medical Systems Innovation Center - Silicon Valley holds about 0.031% of archive notices alongside 32 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 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.
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 sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 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.
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 tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 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.
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
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 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.

American Medical Systems In… holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Abbott Laboratories, Inc 32 Teleflex Medical INC 32 CooperVision, Inc. 33 Custom Healthcare Systems, Inc. 33

Frequently Asked Questions

How many federal recall notices name American Medical Systems In…? ▼
PlainRecalls indexes 32 distinct federal recall events naming American Medical Systems Innovation Center - Silicon Valley, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does American Medical Systems In… sit among other recalling firms? ▼
American Medical Systems Innovation Center - Silicon Valley ranks #521 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of American Medical Systems In…'s notices? ▼
FDA Devices accounts for 32 of this firm's 32 indexed notices.
What product category dominates American Medical Systems In…'s filing book? ▼
Filings for American Medical Systems Innovation Center - Silicon Valley span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
American Medical Systems Innovation Center - Silicon Valley: 32 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming American Medical Systems Innovation Center - Silicon Valley; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026