American Optisurgical Inc

FDA recalling firm · 4 enforcement events · 4 product records · 2012–2013 · CA

American Optisurgical Inc has 4 FDA enforcement events on this register (4 product records) between 2012 and 2013: 4 device; the busiest year was 2013 with 3.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
30 Apr 2013	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…	Device	Class II	1	Terminated
30 Apr 2013	FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.	Device	Class II	1	Terminated
30 Mar 2013	American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.	Device	Class II	1	Terminated
22 Feb 2012	TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated…	Device	Class II	1	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for American Optisurgical Inc by year initiated.

Questions and answers

How many FDA recalls has American Optisurgical Inc had?

4 enforcement events (4 product records) on this register, 2012–2013: 4 device.

Are any American Optisurgical Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are American Optisurgical Inc recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.