Food, drugs, devices › Winco Mfg., LLC
Device recall: Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home
Winco Mfg., LLC (Ocala, FL) initiated this device recall on 2 Apr 2015; FDA lists 13 product records under event 71496, classified Class II.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Dec 2016. Initiation: voluntary: firm initiated. Winco Mfg., LLC has 5 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Winco Mfg., LLC, Ocala, FL.
Reason for recall
"Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards."
Distribution
"Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2391-2015 | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities) | 1 chair | Class II | Terminated | 26 Aug 2015 |
| Z-2392-2015 | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 1 chair | Class II | Terminated | 26 Aug 2015 |
| Z-2393-2015 | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 1 chair | Class II | Terminated | 26 Aug 2015 |
| Z-2394-2015 | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 4 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2395-2015 | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 30 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2396-2015 | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 1 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2397-2015 | Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 3 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2398-2015 | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 2 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2399-2015 | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 1 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2400-2015 | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 32 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2401-2015 | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. | 27 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2402-2015 | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities) | 29 chairs | Class II | Terminated | 26 Aug 2015 |
| Z-2403-2015 | 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) | 1 chairs | Class II | Terminated | 26 Aug 2015 |
Context
Other enforcement events for Winco Mfg., LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jun 2016 | TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiv | Device | Class II | 3 |
| 6 Sep 2013 | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, | Device | Class II | 4 |
| 24 Sep 2012 | PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position reclin | Device | Class II | 4 |
| 10 Jul 2012 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Li | Device | Class II | 2 |
All 5 events for Winco Mfg., LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.