OPTI Medical Systems recalls
OPTI Medical Systems has 3 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 25 Aug 2021. 1 is still ongoing. The most frequent reason is device malfunction.
Total recalls3since 2012
Last 12 months0reported
Class I00% of total
Ongoing1latest 25 Aug 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why opti medical systems is recalled
Product types
By year
Ongoing opti medical systems recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opti Sars-CoV-2 Rt-pcr Test recalled by OPTI Medical Systems | OPTI Medical Systems | Other | 10 states |
All opti medical systems recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Opti Sars-CoV-2 Rt-pcr Test recalled by OPTI Medical Systems | OPTI Medical Systems | Other | 10 states |
| Device | CLASS II | Model BP7507 Opti Lion E-Plus Cassettes 25 Cassettes with Sample recalled | OPTI Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | BP7561 Opti Cca-ts B-Lac Cassette recalled by OPTI Medical Systems | OPTI Medical Systems | Device Malfunction | 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.