Breg, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000018362 FEI 3010694026
Breg, Inc. is a medical device manufacturer based in the United States, with 4,628 devices listed and 15 FDA recalls as of 14 Nov 2026.
- Devices
- 4,628
- Registrations
- EUDAMEDFDA
- FDA recalls
- 151 ongoing
Registry facts
- Registries
- EUDAMED 3,000
- FDA GUDID 68
- Device classes
- EU Class I 2,955
- FDA Class I 42
- EU Class IIa 2
- FDA Class II 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- MDSS GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000018362
- FDA FEI 3010694026
- DUNS 604483321
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- MDSS GmbHDE
What Breg, Inc. makes
Breg, Inc. manufactures orthopedic devices including inflatable hot/cold therapy packs with electric pumps, circulating-fluid localized thermal therapy system packs and control units, cervical spine collars, lumbar spine orthoses, knee support orthoses, and general surgical procedure kits that are non-medicated and single-use.
The company's portfolio includes devices classified as Class I, Class II, Class IIa, and U, and is listed in regulatory registries including eudamed, fda_510k, and fda_udi. Breg, Inc. is based in the US.
Catalogue
Search and filter all 4,628 devicesShowing 1-50 of 4,628
Company details
- EUDAMED SRN
- US-MF-000018362
- FDA FEI number
- 3010694026
- DUNS number
- 604483321
- EUDAMED status
- Active
- EUDAMED registered name
- Breg, Inc.
- EUDAMED abbreviated name
- Breg
- Registered address
- 2382, Faraday Avenue, Suite 300, 92008, Carlsbad, United States
- mzamora@breg.com
- Phone
- 8003210607
- PRRC contact
- Monique Zamora
FDA recalls
FDA recall records list 13 recalls initiated by Breg, Inc., the earliest on 2013-01-14 and the most recent on 2023-09-13. By recorded status: 1 ongoing and 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 8
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 13 Sep 2023 Z-0231-2024 Class II Ongoing Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
Full distribution text
- 13 Sep 2023 Z-0231-2024 Class II Ongoing Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
2017
- 30 Mar 2017 Z-1901-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1902-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1903-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1904-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1905-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1906-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1907-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- 30 Mar 2017 Z-1908-2017 Class II Terminated They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
2014
- 14 Mar 2014 Z-1446-2014 Class II 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.
Show all 15 recalls
2014
- 14 Mar 2014 Z-1447-2014 Class II 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.
2013
- 14 Jan 2013 Z-0803-2013 Class II 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.
- 14 Jan 2013 Z-0804-2013 Class II 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.
2010
- 11 Aug 2010 Z-2326-2012 Class II Terminated This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
2009
- 18 Jun 2009 Z-1989-2009 Unclassified (pre-2012) Terminated Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.
Frequently asked questions
How many devices does Breg, Inc. have in the registry?
The registry currently lists 4628 devices for Breg, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Breg, Inc.'s devices?
Among its 50 most recently registered devices, Breg, Inc. has devices listed in EUDAMED (50 devices).
What risk classes do Breg, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Breg, Inc.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
Are there FDA recall records for Breg, Inc.?
FDA recall records list 15 recalls initiated by Breg, Inc., the most recent initiated on 13 Sep 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Breg, Inc. in the registry?
The most recently registered devices listed for Breg, Inc. include POLAR CARE INTL POWER SUPPLY, 6V, CALF PAD KIT HI-AT DUO SHORT RT XS, Z12 OA CSTM AL and CX2K PREFAB RT XXL.