CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report

TX1 Tissue Removal System Console recalled by American Optisurgical

American Optisurgical is recalling American Optisurgical's TX1 Tissue Removal System Console, distributed in 31 states. The recall was initiated on 30 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial#: 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

Quantity recalled194 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1516-2013
FDA event ID: 65113
Recalling firm: American Optisurgical, Lake Forest, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Mar 2013
FDA classified: 6 Jun 2013
Reported: 12 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

30 Mar 2013	Recall initiated by company
6 Jun 2013	Classified by FDA	+68 days
12 Jun 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.

Where it was distributed

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.

Alabama Arkansas Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Kentucky Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska New Jersey

Questions about this recall

Is TX1 Tissue Removal System Console recalled?

Yes. American Optisurgical recalled TX1 Tissue Removal System Console on 30 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1516-2013.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from American Optisurgical

All 4

Reported	Class	Recall	Company	Reason	Where
19 Jun 2013Device	CLASS II	TX1 Tissue Removal System disposable handpieces recalled	American Optisurgical	Foreign Material	Nationwide
12 Jun 2013Device	CLASS II	FAST Procedure Kit recalled by American Optisurgical	American Optisurgical	Sterility	Nationwide
27 Jun 2012Device	CLASS II	TX1 Tissue Removal System Console recalled by American Optisurgical	American Optisurgical	Foreign Material	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide