The Recall Desk
HighFDA (Devices)·Z-0231-2024·Announced 2023-11-15

Breg Folding Walkers With Wheels Recalled for Misaligned Wheels

Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device has a confirmed structural defect (misaligned wheels) that poses a risk of falls and loss of support for users. No injuries or illnesses have been reported. It qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Breg Inc is recalling 11,193 BREG REF 100519-000 folding walkers with wheels distributed across the United States. The walkers were manufactured with misaligned wheels that do not meet product specifications.

Misaligned wheels on a walker can affect stability and balance, potentially increasing the risk of falls or loss of support during use.

The affected walkers were distributed nationally across all U.S. states. Consumers who own this model should stop using the product. Affected lot numbers include CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, and CM82531223. For replacement or return instructions, consumers should contact Breg Inc.

The recalled product

Product
BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
Manufacturer
Breg Inc
Hazard
  • fall-risk
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • CM82293923
  • CM82293823
  • CM82442923
  • CM82457323
  • CM82457423
  • CM82442823
  • CM82457523
  • CM82531023
  • CM82531223

Distribution

Distributed in 41 states:

  • 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
  • WY