FDA Devices recall · Reported June 12, 2013
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
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,…
American Optisurgical Inc recalled American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit… - a moderate-severity action.
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit… was recalled by American Optisurgical Inc in June 12, 2013. Reason: The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety pro…. Check the official notice for the remedy. Verify recall #Z-1516-2013 with the FDA Devices before acting.
The recall
American Optisurgical Inc issued this moderate-severity FDA Devices recall-The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety pro….
- Moderate
- severity level
- 194 units
- affected scope
- Class II
- classification
- June 12, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1516-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1516-2013 |
| Date reported | June 12, 2013 |
| Date initiated | March 30, 2013 |
| Recalling firm | American Optisurgical Inc |
| Firm location | Lake Forest, CA |
| Affected scope | 194 units |
| Distribution | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1516-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026