Ortho8 recalls

Ortho8 has 2 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 25 Aug 2021. 2 are still ongoing. The most frequent reason is sterility.

Total recalls2since 2021
Last 12 months0reported
Class I00% of total
Ongoing2latest 25 Aug 2021

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why ortho8 is recalled

Product types

By year

Ongoing ortho8 recalls

2 active
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIEvexia Luxe Dvt Prevention Device, Aid recalled by Ortho8Ortho8SterilityNationwide
DeviceCLASS IICIRCUL8 Luxe Dvt Prevention Device, Aid recalled by Ortho8Ortho8SterilityNationwide

All ortho8 recalls, newest first

2 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIEvexia Luxe Dvt Prevention Device, Aid recalled by Ortho8Ortho8SterilityNationwide
DeviceCLASS IICIRCUL8 Luxe Dvt Prevention Device, Aid recalled by Ortho8Ortho8SterilityNationwide

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.