FDA Medical Device Recalls (openFDA)
Winco Mfg., LLC: Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
- Recall number
- Z-2400-2015
- Recalling firm
- Winco Mfg., LLC
- Product
- Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
- Status
- Terminated
- Initiated
- 2015-04-02
- Posted
- 2015-08-14
- Terminated
- 2016-12-14
- Reason
- Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
- Root cause
- Nonconforming Material/Component
- Action
- Winco sent a field correction letter dated April 2, 2015, to all affected customers The letter identified the product, the problem, and the action to be taken by the customer. Winco instructed customers that they will replace the recliners at no charge to the customer. Winco will provide detailed instructions for the replacement of the seats by their facility staff. Winco will extend the remaining warranty on the entire chair for a period of 6 months as compensation. If product was further distributed customers were instructed to notify those customers of the field correction. Customers were asked to complete and return the enclosed field correction response form as soon as possible. Customers with questions should contact Customer Care Monday-Friday 8:30 AM-5:00 PM EST at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929.
- Quantity
- 32 chairs
- Distribution
- Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
- Lot, serial or model codes
- Model Number: 6940, Serial Numbers: 694A106059, 694A106060, 694A106112, 654A105206, 654A105207, 694A106090, 694A106091, 694A106092, 694A106093, 694A106094, 694A106095, 694A106096, 694A106097, 694A106098, 694A106099, 694A106034, 694A106035, 694A106036, 694A106037, 694A106038, 694A106039, 694A106040, 694A106041, 694A106042, 694A106043, 694A106044, 694A106045, 694A106087, 694A106088, 694A106089, 694A106058 and 694A106099
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INN
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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