FDA Medical Device Recalls (openFDA)
R82 A/S: 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)
- Recall number
- Z-1315-2019
- Recalling firm
- R82 A/S
- 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)
- Status
- Terminated
- Initiated
- 2019-03-28
- Posted
- not on file
- Terminated
- 2023-12-15
- Reason
- Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
- Root cause
- Device Design
- Action
- The firm notified the US importer by email on 03/28/2019. The letter explained the problem and requested that the plastic joint connecting the back to the seat base be replaced. The importer will notify the distributors (dealers) of the issue and provide the replacement kits when they arrive. The distributors (dealers) will be performing the field corrections.
- Quantity
- 68 units
- Distribution
- US in the states of NC
- Lot, serial or model codes
- 953121-00, Serial Numbers: 396362, 408283, 420577 953126-00, Serial Numbers: 388456 953131-00, Serial Numbers: 458258 953132-00, Serial Numbers: 384942, 385290, 388501, 418621 935135-00, Serial Numbers: 424406, 424407, 424990, 424991, 427314, 427315, 427316, 427317, 427318, 427319 935136-00, Serial Numbers: 395926, 438528, 442346 953211-00, Serial Numbers: 388448 953221-00, Serial Numbers: 397966, 398981, 408859, 415846, 415847, 418207, 418208, 418209, 421084, 423947, 439833, 448668, 457473 953222-00, Serial Numbers: 389328, 390937, 398116, 401269, 401270, 401271, 403002, 403003, 407903, 407904, 408008, 447674, 447675, 447676, 466069, 472310, 472311 953225-00, Serial Numbers: 449990 953226-00, Serial Numbers: 386225, 450151 953231-00, Serial Numbers: 408215, 408595, 462750 953232-00, Serial Numbers: 402148, 404886, 405148, 405157, 424014, 432987, 459042 953236-00, Serial Numbers: 386256, 412649
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INM
- Firm FEI
- 3001657382
- Firm city
- Gedved
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28