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Breg, Inc.

United States·US-MF-000018362

Last updated September 17, 2026

Information

Country: United States
Address: 2382, Faraday Avenue, Suite 300, Carlsbad, United States
Website: breg.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8003210607
PRRC Contact: Monique Zamora
EUDAMED SRN: US-MF-000018362
FDA FEI Number: 3010694026
DUNS Number: 604483321

Catalogue (251)

Page 6 of 6

Device	Model / Reference	Registries	Class	Status
Pc Wave International Adapter Kit	100718-000	EUDAMED	Class I	Active

Related Companies

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MDSS GmbH DE

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 13, 2023	Z-0231-2024	—	open, classified	Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Mar 30, 2017	Z-1902-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1906-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1904-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1905-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1903-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1908-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1907-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 30, 2017	Z-1901-2017	—	terminated	They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Mar 14, 2014	Z-1447-2014	—	terminated	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.
Mar 14, 2014	Z-1446-2014	—	terminated	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.
Jan 14, 2013	Z-0804-2013	—	terminated	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.
Jan 14, 2013	Z-0803-2013	—	terminated	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.