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WINCO MFG., LLC

Last updated May 26, 2026

Information

Country: US
Address: —
Website: wincomfg.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-237-3377
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 963886457

Catalogue (88)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Winco	525	FDA UDI	Class I	Active
Winco	540	FDA UDI	Class I	Active
Winco	529	FDA UDI	Class I	Active
Winco	5P14 Vero	FDA UDI	Class I	Active
Winco	6P14 Vero	FDA UDI	Class I	Active
Winco	5P00 Vero	FDA UDI	Class I	Active
Winco	586	FDA UDI	Class I	Active
Winco	5X5 Vero	FDA UDI	Class I	Active
Winco	6X1 Vero	FDA UDI	Class I	Active
Winco	5Y4 Vero	FDA UDI	Class I	Active
Winco	690	FDA UDI	Class I	Active
TransMotionMedical	S550	FDA UDI	Class II	Active
Winco	567	FDA UDI	Class I	Active
Winco	2574	FDA UDI	Class I	Active
TransMotionMedical	S999	FDA UDI	Class II	Active
Winco	5P13 Vero	FDA UDI	Class I	Active
Winco	5Y5 Vero	FDA UDI	Class I	Active
Winco	5P58 Vero	FDA UDI	Class I	Active
Winco	6X0 Vero	FDA UDI	Class I	Active
Winco	5P10 Vero	FDA UDI	Class I	Active
Winco	528	FDA UDI	Class I	Active
Winco	5P48 Vero	FDA UDI	Class I	Active
Winco	6P10 Vero	FDA UDI	Class I	Active
Winco	6P43 Vero	FDA UDI	Class I	Active
Winco	5P43 Vero	FDA UDI	Class I	Active
TransMotionMedical	S675	FDA UDI	Class II	Active
Winco	695	FDA UDI	Class I	Active
Winco	6Y1 Vero	FDA UDI	Class I	Active
Winco	590	FDA UDI	Class I	Active
Winco	5P04 Vero	FDA UDI	Class I	Active
Winco	675	FDA UDI	Class I	Active
Tmm	S400	FDA UDI	Class I	Active
Winco	585	FDA UDI	Class I	Active
Winco	655	FDA UDI	Class I	Active
Winco	5P03 Vero	FDA UDI	Class I	Active
Winco	5P50 Vero	FDA UDI	Class I	Active
TransMotionMedical	S750	FDA UDI	Class II	Active
Winco Stretchair	K110671	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (33)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 29, 2016	Z-0064-2017	—	terminated	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Jun 29, 2016	Z-0066-2017	—	terminated	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Jun 29, 2016	Z-0065-2017	—	terminated	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Apr 2, 2015	Z-2402-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2392-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2393-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2397-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2396-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2401-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2395-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2398-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2403-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2391-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2400-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2394-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Apr 2, 2015	Z-2399-2015	—	terminated	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
Sep 6, 2013	Z-1114-2014	—	terminated	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Sep 6, 2013	Z-1116-2014	—	terminated	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Sep 6, 2013	Z-1115-2014	—	terminated	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Sep 6, 2013	Z-1117-2014	—	terminated	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
Sep 24, 2012	Z-0779-2013	—	terminated	The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Sep 24, 2012	Z-0780-2013	—	terminated	The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Sep 24, 2012	Z-0778-2013	—	terminated	The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Sep 24, 2012	Z-0777-2013	—	terminated	The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.
Jul 10, 2012	Z-0031-2013	—	terminated	Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Jul 10, 2012	Z-0032-2013	—	terminated	Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Feb 6, 2012	Z-1457-2012	—	terminated	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Feb 6, 2012	Z-1460-2012	—	terminated	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Feb 6, 2012	Z-1458-2012	—	terminated	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Feb 6, 2012	Z-1461-2012	—	terminated	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Feb 6, 2012	Z-1459-2012	—	terminated	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this
Oct 17, 2011	Z-1106-2012	—	terminated	On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4, 2011 and October 12, 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature.
Oct 17, 2011	Z-1105-2012	—	terminated	On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4, 2011 and October 12, 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inoperable Position Lock Bar feature.