Gedved, Denmark
R82 A/S recalls
4 recalls recorded since 2018, most recently on 8 December 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 December 2021
- Terminated
- 5 September 2023
- Reason
- The chrome surface of the push brace can crack during use, potentially cutting the user.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0569-2022
- R82 by ETAC Push Brace for High-Low
Terminated Class II Medical devices
- Recall started
- 6 March 2020
- Terminated
- 5 September 2023
- Reason
- The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
- Distribution
- NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1858-2020
- Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Terminated Class II Medical devices
- Recall started
- 28 March 2019
- Terminated
- 15 December 2023
- Reason
- Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
- Distribution
- US in the states of NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1315-2019
- Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activi
Ongoing Class II Medical devices
- Recall started
- 30 June 2017
- Reason
- Replacement campaign on all units that have a gas spring head in aluminum.
- Distribution
- Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0441-2019
- Heron toilet and bath chair Model 880505-01 & 880505-11
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.