American Optisurgical’s TX1 Tissue Removal System Console
Medical device recall Z-1516-2013. Published in FDA’s Enforcement Report on Jun 12, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 31 states named in where it went
- 194 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
194 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009 55400010 55400011 55400012 55400013 55400014 55400015 55400016 55400017 55400018 55400019 55400020 55400021 55400022 55400023…
Every code shown here, 1,861 characters
Serial#: 5510124 55400000 55400001 55400002 55400003 55400004 55400005 55400006 55400007 55400008 55400009 55400010 55400011 55400012 55400013 55400014 55400015 55400016 55400017 55400018 55400019 55400020 55400021 55400022 55400023 55400024 55400025 55400026 55400027 55400028 55400029 55400030 55400031 55400032 55400033 55400034 55400035 55400036 55400037 55400038 55400039 55400040 55400041 55400042 55400043 55400044 55400045 55400046 55400047 55400048 55400049 55400050 55400051 55400052 55400053 55400054 55400055 55400056 55400057 55400058 55400059 55400060 55400061 55400062 55400063 55400064 55400065 55400066 55400067 55400068 55400069 55400070 55400071 55400072 55400073 55400074 55400075 55400076 55400077 55400078 55400079 55400080 55400081 55400082 55400083 55400084 55400085 55400086 55400087 55400088 55400089 55400090 55400091 55400092 55400093 55400094 55400095 55400096 55400097 55400098 55400099 55400100 55400101 55400102 55400103 55400104 55400105 55400106 55400107 55400108 55400109 55400110 55400111 55400112 55400113 55400114 55400115 55400116 55400117 55400118 55400119 55400120 55400121 55400122 55400123 55400124 55400125 55400126 55400127 55400128 55400129 55400130 55400131 55400132 55400133 55400134 55400135 55400136 55400137 55400138 55400139 55400140 55400141 55400142 55400143 55400144 55400145 55400146 55400147 55400148 55400149 55400150 55400151 55400152 55400153 55400154 55400155 55400156 55400157 55400158 55400159 55400160 55400161 55400162 55400163 55400164 55400165 55400166 55400167 55400168 55400169 55400170 55400171 55400172 55400173 55400174 55400175 55400176 55400177 55400178 55400179 55400180 55400181 55400182 55400183 55400184 55400185 55400186 55400187 55400188 55400189 55400190 55400191 55400192 55400193 55400194 55400195 55400196 55400197 55400198 55400199 55400200 55400201 55400202 55400203 55400204
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
The states and territories these words name
31 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New York
- Ohio
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 30, 2013.
- FDA classified it on Jun 6, 2013.
- FDA’s Enforcement Report published it on Jun 12, 2013.
- FDA terminated it on Mar 24, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- American Optisurgical Inc, of Lake Forest, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.