Facility

BREG, INC.,

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

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000125378
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	2382 Faraday Avenue Carlsbad, CA, US 92008
Registration status	Active · expires 2026
Parent company	Breg Inc (owner-operator 10041297)
Brand names	VPulse

Activity by year

Recalls (4)

Devices registered here (1)

Sleeve, Limb, Compressible
Product code JOW (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5800

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BREG, INC., (FEI 1000125378) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000125378-breg-inc/

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