American Optisurgical recalls
American Optisurgical has 4 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 19 Jun 2013. The most frequent reason is foreign material.
Total recalls4since 2012
Last 12 months0reported
Class I00% of total
Ongoing0latest 19 Jun 2013
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 100%Class III 0 0%
Why american optisurgical is recalled
Product types
By year
All american optisurgical recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TX1 Tissue Removal System disposable handpieces recalled | American Optisurgical | Foreign Material | Nationwide |
| Device | CLASS II | TX1 Tissue Removal System Console recalled by American Optisurgical | American Optisurgical | Packaging Defects | 31 states |
| Device | CLASS II | FAST Procedure Kit recalled by American Optisurgical | American Optisurgical | Sterility | Nationwide |
| Device | CLASS II | TX1 Tissue Removal System Console recalled by American Optisurgical | American Optisurgical | Foreign Material | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.