R82 A/S
R82 A/S has 4 FDA enforcement events on this register (4 product records) between 2017 and 2021: 4 device; the busiest year was 2017 with 1.
0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 8 Dec 2021 | R82 by ETAC Push Brace for High-Low | Device | Class II | 1 | Terminated |
| 6 Mar 2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 | Device | Class II | 1 | Terminated |
| 28 Mar 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: Activity chair (wheelchair) | Device | Class II | 1 | Terminated |
| 30 Jun 2017 | Heron toilet and bath chair Model 880505-01 & 880505-11 | Device | Class II | 1 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has R82 A/S had?
4 enforcement events (4 product records) on this register, 2017–2021: 4 device.
Are any R82 A/S recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are R82 A/S recalls?
4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.