Agency classClass IIOur severity:High FDA (Devices)·Z-2398-2015·Announced 2015-08-26

Winco Designer Care Cliner chairs recalled for non-compliant foam

Winco Mfg., LLC is recalling two Designer Care Cliner chairs because the foam used was not fire retardant as required.

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 does not meet fire retardant standards, representing a risk of harm (fire) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Winco Mfg., LLC is recalling two units of the Winco Designer Care Cliner chair, Model Number 6700, with Serial Number 670A101355. The recall is due to a material defect where the foam shipped for the chairs was classified as fire retardant but was actually standard foam that does not meet fire retardant standards.

The affected chairs were distributed nationwide, including in California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, and Washington. These chairs are intended for use in oncology, dialysis, hospital recovery, home dialysis, and physician facilities.

Consumers and facility managers should stop using the affected chairs immediately and contact Winco Mfg., LLC for instructions on how to return the product or obtain a remedy.

The recalled product

Product: Winco Designer Care Cliner - 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: 2

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 (2)

Model Number: 6700
Serial Numbers: 670A101355 and 670A101355

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