CLASS II Device recall · Reported 22 May 2019 · FDA Enforcement Report

Wombat Living, Size recalled by R82 A/s

R82 A/s is recalling Wombat Living, Size 3, distributed in North Carolina. The recall was initiated on 28 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes953121-00, 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
Quantity recalled68 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1315-2019
FDA event ID
82571
Recalling firm
R82 A/s, Gedved
Classification
Class II
Status
Terminated
Recall initiated
28 Mar 2019
FDA classified
11 May 2019
Reported
22 May 2019
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Foreign Material

Timeline

28 Mar 2019Recall initiated by company
11 May 2019Classified by FDA+44 days
22 May 2019Published in enforcement report+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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)

Where it was distributed

US in the states of NC

North Carolina

Questions about this recall

Is Wombat Living, Size 3 recalled?

Yes. R82 A/s recalled Wombat Living, Size 3 on 28 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1315-2019.

Why was it recalled?

Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.

Which lots are affected?

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

Where was it sold?

US in the states of NC

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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