TX1 Tissue Removal System Console — Class II medical device recall Z-1817-2012

Terminated recall by American Optisurgical Inc, reported 2012-06-27, distributed nationwide. Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chanc

Recall number	`Z-1817-2012`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	American Optisurgical Inc, Lake Forest, CA, United States
Recall initiated	2012-02-22
Classified	2012-06-15
Reported by FDA	2012-06-27
Terminated	2012-06-15
Distributed	Nationwide (US)
Quantity	5 units
Serial numbers	`55400001`, `55400002`, `55400003`
Model numbers	`TX1`

Product

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 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.

Reason for recall

Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1817-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.