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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Medical Device — Mobility Aid
- Affected units
- 11,193
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
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