Agency classClass IIOur severity:High FDA (Devices)·Z-2403-2015·Announced 2015-08-26

Winco Patient Recliner Recalled for Non-Fire-Retardant Foam

Winco Mfg. is recalling specific patient recliners because the foam used was standard foam rather than fire-retardant foam, failing to meet 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 hazard due to non-compliant foam in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Winco Mfg., LLC is recalling the Winco Nocturnal Elite Care Cliner, a lay-flat clinical patient recliner with Trendelenburg capability. The recall involves Model Number 6980 with Serial Number 698101503. The product was distributed nationwide, including in California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas, and Washington.

The recall was initiated because a shipment of foam intended for the chairs was received classified as fire-retardant but was actually standard foam. Consequently, the product does not meet fire-retardant standards. This defect presents a fire hazard.

Consumers who possess this specific model and serial number should stop using the product and contact Winco Mfg., LLC for instructions on how to proceed with the recall.

The recalled product

Product: Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities)
Manufacturer: Winco Mfg., LLC
Category: Medical Device — Patient Recliner
Hazard: fire
Affected units: 1

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: 6980
Serial Numbers: 698101503

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 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