FDA-Device2023-11-15Class II

BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

Breg Inc
Hazard

Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

Sold states
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A
Affected count
11,193 units
Manufactured in
2382 Faraday Ave, Carlsbad, CA, United States
Products
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0231-2024

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