Breg, Inc.,
2382 Faraday Avenue, Carlsbad, CA, US
Registered product codes
30 product codes
Recent MDR events
370 on file
- CERVICAL COLLARFeb 17, 2026MalfunctionMW5183931
- BREG POLAR CAREJan 15, 2026Malfunction24078673
- THERAPEUTIC BOOTJan 12, 2026InjuryMW5182037
- BREG POLAR CARE REUSABLE GEL PACKSep 15, 2025Malfunction23051908
- GEL WRAP KNEE W/ 4PKSJul 8, 2024Malfunction2028253-2024-00001
- GEL WRAP KNEEMay 20, 2024MalfunctionMW5155151
- POLAR CARE CUBEFeb 3, 2023Injury2028253-2023-00001
- BREGJan 10, 2023Malfunction16130062
- POLAR CARE KODIAKOct 12, 2022Malfunction2028253-2022-00004
- POLAR CARE KODIAKSep 16, 2022Malfunction15437552
Recalls
15 on file
- Open, ClassifiedNov 3, 2023
Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedMay 2, 2017
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
View FDA record ↗ - TerminatedApr 10, 2014
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.
View FDA record ↗
Compliance history
Matched by FEI 1000125378.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.