Agency classClass IIOur severity:High FDA (Devices)·Z-2400-2015·Announced 2015-08-26

Winco Elite Care Chairs Recalled for Fire Retardant Foam Mislabeling

Winco Mfg. is recalling 32 Elite Care chairs because foam shipped as fire retardant was actually standard foam, failing safety standards.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a fire safety defect in a medical device where the foam fails to meet fire retardant standards. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, corresponding to a High severity score.

Plain-English summary

Winco Mfg., LLC is recalling 32 units of the Winco Elite Care Cliner w/Swing Away Arms Standard chair with Nylon Casters. The recall involves Model Number 6940 and specific serial numbers listed in the agency record. These chairs are used in oncology, dialysis, hospital recovery, home dialysis, and physician facilities.

The recall was initiated because a shipment of foam intended for the chairs was received classified as fire retardant but was actually standard foam. As a result, the foam does not meet fire retardant standards. The affected units were distributed nationwide, including in California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, and Washington.

Consumers and facility managers should stop using the affected chairs and contact Winco Mfg., LLC for further instructions on the recall.

The recalled product

Product: Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
Manufacturer: Winco Mfg., LLC
Category: Medical Device — Hospital Furniture
Hazard: fire
Affected units: 32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Number: 6940
Serial Numbers: 694A106059
694A106060
694A106112
654A105206
654A105207
694A106090
694A106091
694A106092
694A106093
694A106094
694A106095
694A106096
694A106097
694A106098
694A106099
694A106034
694A106035
694A106036
694A106037

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Winco Mfg., LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Same manufacturer · Winco Mfg., LLC

See all →

Moderate
Winco TMM5 Mobile Surgical Stretcher-Chair Recalled for Design Non-Conformance
FDA (Devices) · 2016-10-19
Moderate
Winco TMM4 Series Treatment Chair Recalled for Non-Conforming Component
FDA (Devices) · 2016-10-19
Moderate
Winco TMM3 Video-Fluoroscopy Stretcher-Chair Recalled for Non-Conforming Component
FDA (Devices) · 2016-10-19
High
Winco Drop Arm Care Cliner Chairs Recalled for Fire Hazard
FDA (Devices) · 2015-08-26
Severe
Winco Designer Care Cliner Recalled for Non-Fire Retardant Foam
FDA (Devices) · 2015-08-26

Same hazard · fire