Medical device recalls Moderate risk

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

Recall date
September 13, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0231-2024
FDA classification
Class II
Brand / firm
Breg Inc
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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