Food, drugs, devices › R82 A/S
Device recall: Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 95322
R82 A/S (Gedved) initiated this device recall on 28 Mar 2019; FDA lists 1 product record under event 82571, classified Class II.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 15 Dec 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, Denmark.
Reason for recall
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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: Activity chair (wheelchair) | 68 units | Class II | Terminated | 22 May 2019 |
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 |
| 6 Mar 2020 | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 8698 | 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: "Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat."
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: "US in the states of NC"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Dec 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.