CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report

Premier Lifecare Recliner 5400 With Cal Tb 133 Upgrade recalled

Winco Mfg is recalling Premier Lifecare Recliner 5400 With Cal Tb 133 Upgrade Purchased Jan 01, 2011 To August, distributed nationwide in the US. The recall was initiated on 24 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.

Quantity recalled95 units (all models)

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-0777-2013
FDA event ID: 63651
Recalling firm: Winco Mfg, Ocala, FL
Classification: Class II
Status: Terminated
Recall initiated: 24 Sep 2012
FDA classified: 4 Feb 2013
Reported: 13 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Sep 2012	Recall initiated by company
4 Feb 2013	Classified by FDA	+133 days
13 Feb 2013	Published in enforcement report	+9 days

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

Reason for recall

The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.

Product as listed by the FDA

PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.

Where it was distributed

Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.

Nationwide California Florida Illinois Massachusetts Maryland Minnesota New Mexico New York Ohio Oklahoma Texas

Stores named: WinCo

Questions about this recall

Is Premier Lifecare Recliner 5400 With Cal Tb 133 Upgrade Purchased Jan 01, 2011 To August recalled?

Yes. Winco Mfg recalled Premier Lifecare Recliner 5400 With Cal Tb 133 Upgrade Purchased Jan 01, 2011 To August on 24 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0777-2013.

Why was it recalled?

The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.

Which lots are affected?

Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106.

Where was it sold?

Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.

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
26 Aug 2015Device	CLASS II	Winco Designer Care Cliner - with Nylon Casters Oncology recalled	Winco Mfg	Other	Nationwide
26 Aug 2015Device	CLASS II	Winco Elite Care Cliner w/Swing Away Arms X-Large recalled by Winco Mfg	Winco Mfg	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide