Agency classClass IIOur severity:High FDA (Devices)·Z-2395-2015·Announced 2015-08-26

Winco Drop Arm Care Cliner Chairs Recalled for Fire Hazard

Winco Mfg. is recalling 30 Drop Arm 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 hazard in a medical device where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Winco Mfg., LLC is recalling 30 units of the Winco Drop Arm Care Cliner Standard chair, Model Number 6550. The recall involves specific serial numbers ranging from 655A108119 to 655A108148. These chairs are used in oncology, dialysis, hospital recovery, home dialysis, and physician facilities.

The recall was initiated because the shipment of foam used for the chairs was received classified as fire retardant but was actually standard foam that would not meet fire retardant standards. This discrepancy creates a fire hazard.

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

The recalled product

Product: Winco Drop Arm Care Cliner 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: 30

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: 6550
Serial Numbers: 655A108119
655A108120
655A108121
655A108122
655A108123
655A108124
655A108125
655A108126
655A108127
655A108128
655A108129
655A108130
655A108131
655A108132
655A108133
655A108134
655A108135
655A108136
655A108137

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
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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 Care Cliner Standart Steel Casters 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