CLASS II Device recall · Reported 19 Jun 2013 · FDA Enforcement Report

TX1 Tissue Removal System disposable handpieces recalled

American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01

Quantity recalled1,436 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-1518-2013
FDA event ID: 65108
Recalling firm: American Optisurgical, Lake Forest, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Apr 2013
FDA classified: 7 Jun 2013
Reported: 19 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

30 Apr 2013	Recall initiated by company
7 Jun 2013	Classified by FDA	+38 days
19 Jun 2013	Published in enforcement report	+12 days

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

Reason for recall

American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

Where it was distributed

Worldwide Disitribution - USA Nationwide in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming and the countries of Quezon City, Philippines, Singapore, and Panama City, Panama.

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

Questions about this recall

Is TX1 Tissue Removal System disposable handpieces recalled?

Yes. American Optisurgical recalled TX1 Tissue Removal System disposable handpieces on 30 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1518-2013.

Why was it recalled?

Which lots are affected?

Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01

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
12 Jun 2013Device	CLASS II	TX1 Tissue Removal System Console recalled by American Optisurgical	American Optisurgical	Packaging Defects	31 states
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

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