Medical DeviceFeb 16, 2022
R82 A/S R82 by ETAC Push Brace for High-Low recall — FDA Z-0569-2022
The chrome surface of the push brace can crack during use, potentially cutting the user.
Class IIFDA: TerminatedR82 A/S
Recall history in this database
Classification mix: Class II: 2.
Medical DeviceMay 22, 2019
R82 A/S Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00 recall — FDA Z-1315-2019
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Class IIFDA: TerminatedR82 A/S
Understanding this recall history
This page summarizes recall records in which the official source identifies R82 A/S 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.