CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report

Breg REF 100519-000 Walker Folding Walker With Wheels Utilized as recalled

Breg is recalling Breg REF 100519-000 Walker Folding Walker With Wheels Utilized as a, distributed in 41 states. The recall was initiated on 13 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223

Quantity recalled11,193 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0231-2024
FDA event ID: 93114
Recalling firm: Breg, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Sep 2023
FDA classified: 3 Nov 2023
Reported: 15 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Wheelchairs, Beds & Lifts

Timeline

13 Sep 2023	Recall initiated by company
3 Nov 2023	Classified by FDA	+51 days
15 Nov 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was 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

Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Is Breg REF 100519-000 Walker Folding Walker With Wheels Utilized as a recalled?

Yes. Breg recalled Breg REF 100519-000 Walker Folding Walker With Wheels Utilized as a on 13 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0231-2024.

Why was it recalled?

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

Which lots are affected?

Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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