# Breg, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/breg-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000018362
- FDA FEI: 3010694026
- DUNS: 604483321

## Figures

- Devices: 4,628
- FDA recalls (matched to the firm by name): 15, 1 ongoing

## Registry facts

*The 3,000 best-ranked devices of 4,628.*

- 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
- EMDN [Y06 External prostheses and orthoses](https://devicerts.com/categories/emdn/Y06): 2,932 devices
- EMDN [M90 Devices for general and specialist dressings - various](https://devicerts.com/categories/emdn/M90): 25 devices

## Sites and related companies

- Authorised representative: [MDSS GmbH](https://devicerts.com/representatives/mdss-gmbh-de-ar-000005430) (Germany)

## Devices

The first 50 of 4,628, in the order of the canonical page, which lists them all.

- [Polar Care Intl Power Supply, 6V](https://devicerts.com/devices/polar-care-intl-power-supply-6v-100316-000) · ref 100316-000 · Class IIa · EUDAMED · status: Active
- [Calf Pad Kit Hi-At Duo Short Rt Xs](https://devicerts.com/devices/calf-pad-kit-hi-at-duo-short-rt-xs-ed030201) · ref ED030201 · Class I · EUDAMED · status: Active
- [Z12 Oa Cstm Al](https://devicerts.com/devices/z12-oa-cstm-al-az215000) · ref AZ215000 · Class I · EUDAMED · status: Active
- [CX2K Prefab Rt Xxl](https://devicerts.com/devices/cx2k-prefab-rt-xxl-22060) · ref 22060 · Class I · EUDAMED · status: Active
- [Revolution 3 Lg Rc 24IN - 28IN](https://devicerts.com/devices/revolution-3-lg-rc-24in-28in-ek029005) · ref EK029005 · Class I · EUDAMED · status: Active
- [Kit Sg Thrstr Leg Ath Ml/Lr L](https://devicerts.com/devices/kit-sg-thrstr-leg-ath-ml-lr-l-ta462107) · ref TA462107 · Class I · EUDAMED · status: Active
- [Calf Pad Kit Hi-Act Axe-D Rt 3XL](https://devicerts.com/devices/calf-pad-kit-hi-act-axe-d-rt-3xl-mg357213) · ref MG357213 · Class I · EUDAMED · status: Active
- [Axiom Elite Athletic Rt S](https://devicerts.com/devices/axiom-elite-athletic-rt-s-pk429203) · ref PK429203 · Class I · EUDAMED · status: Active
- [Duo Lat Comb Inst Athletic Short Rt S](https://devicerts.com/devices/duo-lat-comb-inst-athletic-short-rt-s-ed313203-ci) · ref ED313203-CI · Class I · EUDAMED · status: Active
- [Select Knee Support, W/ Patella Cutout, Neoprene, M](https://devicerts.com/devices/select-knee-support-w-patella-cutout-neoprene-m-sa637005) · ref SA637005 · Class I · EUDAMED · status: Active
- [Boot Mid Calf J Walker Blk Xl](https://devicerts.com/devices/boot-mid-calf-j-walker-blk-xl-bl011009) · ref BL011009 · Class I · EUDAMED · status: Active
- [Thigh Strap Kit Z12/13 S](https://devicerts.com/devices/thigh-strap-kit-z12-13-s-az100003) · ref AZ100003 · Class I · EUDAMED · status: Active
- [CX2K Hp Prefab Rt Xxl](https://devicerts.com/devices/cx2k-hp-prefab-rt-xxl-24860) · ref 24860 · Class I · EUDAMED · status: Active
- [Oa Imp Push Lat Tritech Rt Xl](https://devicerts.com/devices/oa-imp-push-lat-tritech-rt-xl-rk518209) · ref RK518209 · Class I · EUDAMED · status: Active
- [Econ Hinged Knee Am Ob S](https://devicerts.com/devices/econ-hinged-knee-am-ob-s-21712) · ref 21712 · Class I · EUDAMED · status: Active
- [Duo Medial Rt M](https://devicerts.com/devices/duo-medial-rt-m-ed112205-b) · ref ED112205--B · Class I · EUDAMED · status: Active
- [Thigh Pad Kit Hi-At Duo Rt Xxl](https://devicerts.com/devices/thigh-pad-kit-hi-at-duo-rt-xxl-ed027211) · ref ED027211 · Class I · EUDAMED · status: Active
- [Pfs Wrap L](https://devicerts.com/devices/pfs-wrap-l-11364) · ref 11364 · Class I · EUDAMED · status: Active
- [Freestyle Plus Medial, Left Xs](https://devicerts.com/devices/freestyle-plus-medial-left-xs-kn1171-010) · ref KN1171-010 · Class I · EUDAMED · status: Active
- [Adjfit Mc Blk Xl](https://devicerts.com/devices/adjfit-mc-blk-xl-al056009) · ref AL056009 · Class I · EUDAMED · status: Active
- [Lpr Prefab Rt S](https://devicerts.com/devices/lpr-prefab-rt-s-02220) · ref 02220 · Class I · EUDAMED · status: Active
- [WX2K Oa Prefab Rt M](https://devicerts.com/devices/wx2k-oa-prefab-rt-m-25630) · ref 25630 · Class I · EUDAMED · status: Active
- [Z-13 Lt Xl](https://devicerts.com/devices/z-13-lt-xl-ez114109-b) · ref EZ114109--B · Class I · EUDAMED · status: Active
- [Recover Knee Brace Neo Shrt M](https://devicerts.com/devices/recover-knee-brace-neo-shrt-m-00373) · ref 00373 · Class I · EUDAMED · status: Active
- [Axiom-D Elite Rt S](https://devicerts.com/devices/axiom-d-elite-rt-s-pk428203) · ref PK428203 · Class I · EUDAMED · status: Active
- [Kit Sg Thrstr Leg Ath Ml/Lr Xl](https://devicerts.com/devices/kit-sg-thrstr-leg-ath-ml-lr-xl-ta462109) · ref TA462109 · Class I · EUDAMED · status: Active
- [Boot W/Bootie Lo Ez Set Blk Xl](https://devicerts.com/devices/boot-w-bootie-lo-ez-set-blk-xl-al070029bb) · ref AL070029BB- · Class I · EUDAMED · status: Active
- [Calf Pad Kit Everyday Axe-D Lt S](https://devicerts.com/devices/calf-pad-kit-everyday-axe-d-lt-s-mg257103) · ref MG257103 · Class I · EUDAMED · status: Active
- [Kit Sg Duo Sht Ha Ath Mr/Ll Xs](https://devicerts.com/devices/kit-sg-duo-sht-ha-ath-mr-ll-xs-ed321201) · ref ED321201 · Class I · EUDAMED · status: Active
- [Calf Strap Kit Thrstr Rlf Xl](https://devicerts.com/devices/calf-strap-kit-thrstr-rlf-xl-ta010109) · ref TA010109 · Class I · EUDAMED · status: Active
- [Axiom Elite Ath Comb Instrt Xxl](https://devicerts.com/devices/axiom-elite-ath-comb-instrt-xxl-pk529211) · ref PK529211 · Class I · EUDAMED · status: Active
- [Softgait Walker Short Xs](https://devicerts.com/devices/softgait-walker-short-xs-100620-010) · ref 100620-010 · Class I · EUDAMED · status: Active
- [Pad Fus Lat Oa Plus C Rt M+](https://devicerts.com/devices/pad-fus-lat-oa-plus-c-rt-m-14335) · ref 14335 · Class I · EUDAMED · status: Active
- [Sr Wa Ob M](https://devicerts.com/devices/sr-wa-ob-m-06803) · ref 06803 · Class I · EUDAMED · status: Active
- [Pto Hp Airmesh Ob Rt M](https://devicerts.com/devices/pto-hp-airmesh-ob-rt-m-14303) · ref 14303 · Class I · EUDAMED · status: Active
- [Thruster Lgcy Lat Short Gry Lt Xs](https://devicerts.com/devices/thruster-lgcy-lat-short-gry-lt-xs-ta418101) · ref TA418101 · Class I · EUDAMED · status: Active
- [Boot, Conformer, 1, Air, 14-15, Right](https://devicerts.com/devices/boot-conformer-1-air-14-15-right-al241214) · ref AL241214 · Class I · EUDAMED · status: Active
- [CX2K Oa Prefab Rt L](https://devicerts.com/devices/cx2k-oa-prefab-rt-l-25440) · ref 25440 · Class I · EUDAMED · status: Active
- [Calf Pad Kit Hi-Act Axe Rt Xxs](https://devicerts.com/devices/calf-pad-kit-hi-act-axe-rt-xxs-mg347200) · ref MG347200 · Class I · EUDAMED · status: Active
- [Z12 Adjustable Oa Med Lt Xxl](https://devicerts.com/devices/z12-adjustable-oa-med-lt-xxl-az294111-a) · ref AZ294111-A · Class I · EUDAMED · status: Active
- [Softgait Air Walker M](https://devicerts.com/devices/softgait-air-walker-m-100617-030) · ref 100617-030 · Class I · EUDAMED · status: Active
- [Calf Strap Kit Z12 D S](https://devicerts.com/devices/calf-strap-kit-z12-d-s-az108003) · ref AZ108003 · Class I · EUDAMED · status: Active
- [Calf Pad Kit Hi-Act Z13 Sport Lt M](https://devicerts.com/devices/calf-pad-kit-hi-act-z13-sport-lt-m-ez103105) · ref EZ103105 · Class I · EUDAMED · status: Active
- [Thruster Lgcy Med Std Gry Rt L](https://devicerts.com/devices/thruster-lgcy-med-std-gry-rt-l-ta409207) · ref TA409207 · Class I · EUDAMED · status: Active
- [Thigh Pad Kit Hi-Act Axe/Axe-D Rt 4XL](https://devicerts.com/devices/thigh-pad-kit-hi-act-axe-d-rt-4xl-mg346215) · ref MG346215 · Class I · EUDAMED · status: Active
- [Oa Imp Pull Med Tritech Lt Xxl](https://devicerts.com/devices/oa-imp-pull-med-tritech-lt-xxl-rk509111) · ref RK509111 · Class I · EUDAMED · status: Active
- [Lateral Pat Stab Neo 3D Rt S](https://devicerts.com/devices/lateral-pat-stab-neo-3d-rt-s-sa611203) · ref SA611203 · Class I · EUDAMED · status: Active
- [Vectr A Basic Air Tall, Xs](https://devicerts.com/devices/vectr-a-basic-air-tall-xs-97601) · ref 97601 · Class I · EUDAMED · status: Active
- [Duo Lat Comb Inst Athletic Short Lt Xl](https://devicerts.com/devices/duo-lat-comb-inst-athletic-short-lt-xl-ed313109-ci) · ref ED313109-CI · Class I · EUDAMED · status: Active
- [Freerunner Rt L](https://devicerts.com/devices/freerunner-rt-l-100379-240) · ref 100379-240 · Class I · EUDAMED · status: Active

## FDA recalls (matched by name, newest first)

- Z-0231-2024 · Class II · Ongoing · initiated 2023-09-13 · product code ITJ: Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.
- Z-1901-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1902-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1903-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1904-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1905-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1906-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1907-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1908-2017 · Class II · Terminated · initiated 2017-03-30 · product code KGX: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
- Z-1446-2014 · Class II · Terminated · initiated 2014-03-14 · product code IQI: 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.
- Z-1447-2014 · Class II · Terminated · initiated 2014-03-14 · product code IQI: 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.
- Z-0803-2013 · Class II · Terminated · initiated 2013-01-14 · product code ILO: 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.
- Z-0804-2013 · Class II · Terminated · initiated 2013-01-14 · product code ILO: 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.
- Z-2326-2012 · Class II · Terminated · initiated 2010-08-11 · product code KGX: 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.
- Z-1989-2009 · Unclassified (pre-2012) · Terminated · initiated 2009-06-18 · product code ILO: 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.

## Source and citation

- Cite as: Breg, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/breg-inc (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-14
- JSON: <https://devicerts.com/manufacturers/breg-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/breg-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.