Medical DeviceAug 25, 2021
Ortho8 CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis recall — FDA Z-2324-2021
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Class IIFDA: OngoingOrtho8, Inc.
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceAug 25, 2021
Ortho8 EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis recall — FDA Z-2325-2021
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Class IIFDA: OngoingOrtho8, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Ortho8, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.