Wombat Living — Class II medical device recall Z-1315-2019
Terminated recall by R82 A/S, reported 2019-05-22, distributed in NC. Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the
| Recall number | Z-1315-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | R82 A/S, Gedved, Denmark |
| Recall initiated | 2019-03-28 |
| Classified | 2019-05-11 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2023-12-15 |
| Distributed | NC |
| Quantity | 68 units |
| Reason classes | device malfunction |
| Serial numbers | 384942, 385290, 386225, 386256, 388448, 388456, 388501, 389328, 390937, 395926, 396362, 397966, 398116, 398981, 401269, 401270, 401271, 402148, 403002, 403003, 404886, 405148, 405157, 407903, 407904 and 56 more |
| Model numbers | 935-135-00, 935136-00, 953121-00, 953126-00, 953131-00, 953132-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 |
Product
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)
Reason for recall
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1315-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.