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FDA Medical Device Recalls (openFDA)

Winco Mfg., LLC: CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features, plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift, making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.

Recall number
Z-1458-2012
Recalling firm
Winco Mfg., LLC
Product
CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features, plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift, making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion.
Status
Terminated
Initiated
2012-02-06
Posted
2012-04-25
Terminated
2012-07-27
Reason
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
Root cause
Device Design
Action
Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice.
Quantity
1,311 Casters (437 Chairs)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.
Lot, serial or model codes
Model 6550, 6570.
510(k) numbers
not on file
PMA numbers
not on file
Product code
INM
Firm FEI
1027229
Firm city
Ocala
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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