FDA recall Z-0231-2024

Breg Inc · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-09-13
Report date
2023-11-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

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