RegWardenFDA facility compliance records
Company

Breg Inc

4 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2017: 1 recalls; 2023: 1 recalls1’131’14’15’161’17’18’19’20’21’221’23’24’25’26
  • Recalls (4)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2023-09-13
    Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
  • Class IITerminated2017-03-30
    They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
  • Class IITerminated2014-03-14
    Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.
  • Class IITerminated2013-01-14
    The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Breg Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10041297-breg-inc/

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