Food, drugs, devices › R82 A/S
Device recall: Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 8698
FDA enforcement event 85210 is a device recall by R82 A/S of Gedved, N/A, initiated 6 Mar 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 5 Sep 2023. Initiation: voluntary: firm initiated. R82 A/S has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
R82 A/S, Gedved, N/A, Denmark.
Reason for recall
"The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool."
Distribution
"NC"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1858-2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 | 2230 units | Class II | Terminated | 13 May 2020 |
Context
Other enforcement events for R82 A/S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Dec 2021 | R82 by ETAC Push Brace for High-Low | Device | Class II | 1 |
| 28 Mar 2019 | Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 95322 | Device | Class II | 1 |
| 30 Jun 2017 | Heron toilet and bath chair Model 880505-01 & 880505-11 | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "NC"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Sep 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.