Invacare Corporation: Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.

Recall number

Z-3280-2011

Recalling firm

Invacare Corporation

Product

Dual Blue-Release Adult Walkers - Wheeled, and Blue Release Junior Walkers with 5 inch Fixed Wheels, Model Numbers: 6240-5F and 6240-JR5F. The recalled product is packaged four (4) units per shipping box. Product Usage: The walkers are intended for people who need additional support to maintain balance or stability while walking.

Status

Terminated

Initiated

2011-03-02

Posted

2011-09-27

Terminated

2013-07-02

Reason

The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would res

Root cause

Device Design

Action

The firm, Invacare Corporation notified their customers of this recall/corrective action via an 'URGENT RECALL INFORMATION' letter dated April 7, 2011. The letter was sent to the customers by registered mail or Federal Express. The letter informs the customer(s) of the component defect involved and the inherent possibility that over time, a walker wheel(s) could fall off resulting in instability of the product and potential for serious injury to the user of the device. The letter provides a list of the affected units sold to each facility on an enclosed tracking sheet. It also asks that the customer: 1) Examine their stock for the presence of any of the affected walkers and to quarantine any such products found; 2) Complete an attached recall response form indicating the customers receipt and understanding of the instructions provided in the letter and to fax the completed form to the telephone number listed on the bottom of the form. The letter goes on to state that once the faxed back form is received by Invacare, the company will send the customer replacement wheels kits for all affected walkers purchased; 3) the customer is asked upon receipt of the replacement wheel kits to replace the wheels of any units still in stock and discard all of the old wheel parts removed; 4) Lastly, the customer is asked to contact their sub-account customers and notify them of the recall. If the customer have any questions concerning the instructions, call the recall support line at 1-866-567-7899.

Quantity

12,764 walkers were distributed.

Distribution

Worldwide Distribution - USA (nationwide: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, including Puerto Rico and countries of Canada, Columbia, and Israel.

Lot, serial or model codes

All 6240-5F and 6240-JR5F wheeled walkers distributed by the firm between 12/15/2010 and 3/4/2011, are subject to recall/correction.

510(k) numbers

not on file

PMA numbers

not on file

Product code

ITJ

Firm FEI

1525712

Firm city

Elyria

Firm state

OH

Firm country

not on file

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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