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American Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 6 total recalls

American Medical Systems, Inc. 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 (6)

FDA medical device enforcement actions by American Medical Systems, Inc.

Date Product Reason Class
Oct 15, 2014 AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M... During routine periodic packaging testing, AMS identified that in simulated e... Class II
Oct 15, 2014 AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF... During routine periodic packaging testing, AMS identified that in simulated e... Class II
Oct 10, 2014 AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Acces... AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith nee... Class II
Mar 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is u... American Medical Systems, Inc. is initiating a recall on two components of th... Class II
Mar 1, 2013 AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is ... American Medical Systems, Inc. is initiating a recall on two components of th... Class II
Oct 19, 2012 AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US)... American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of ... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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