CLASS II Device recall · Reported 26 Aug 2015 · FDA Enforcement Report

Winco Elite Care Cliner w/Swing Away Arms X-Large recalled by Winco Mfg

Winco Mfg is recalling Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, distributed nationwide in the US. The recall was initiated on 2 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 6950, Serial Numbers: 695104466, 695104467, 695104445, 695104273, 695104460, 695104461, 695104462, 695104463, 695104464, 695104465, 695104450, 695104451, 695104452, 695104431, 695104438, 695104442, 695104444, 695104437, 695104438, 695104439, 695104440, 695104441, 695104442, 695104443, 695104444, 695104439 and 695104437 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041, 694A106042, 694A106043, 694A106044, 694A106045, 694A106087, 694A106088, 694A106089, 694A106058 and 694A106099

Quantity recalled27 chairs

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-2401-2015
FDA event ID: 71496
Recalling firm: Winco Mfg, Ocala, FL
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2015
FDA classified: 14 Aug 2015
Reported: 26 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Apr 2015	Recall initiated by company
14 Aug 2015	Classified by FDA	+134 days
26 Aug 2015	Published in enforcement report	+12 days

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

Reason for recall

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Product as listed by the FDA

Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.

Where it was distributed

Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

Nationwide California Florida Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Mississippi New Jersey New York Oklahoma Tennessee Texas Washington

Stores named: WinCo

Questions about this recall

Is Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis recalled?

Yes. Winco Mfg recalled Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis on 2 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-2401-2015.

Why was it recalled?

Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

Which lots are affected?

Model Number: 6950, Serial Numbers: 695104466, 695104467, 695104445, 695104273, 695104460, 695104461, 695104462, 695104463, 695104464, 695104465, 695104450, 695104451, 695104452, 695104431, 695104438, 695104442, 695104444, 695104437, 695104438, 695104439, 695104440, 695104441, 695104442, 695104443, 695104444, 695104439 and 695104437 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041, 694A106042, 694A106043, 694A106044, 694A106045, 694A106087, 694A106088, 694A106089, 694A106058 and 694A106099

Where was it sold?

Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.

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.

More recalls from Winco Mfg

All 26

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016Device	CLASS II	TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair recalled	Winco Mfg	Other	29 states
19 Oct 2016Device	CLASS II	TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair recalled	Winco Mfg	Other	29 states
19 Oct 2016Device	CLASS II	TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow recalled	Winco Mfg	Other	29 states
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