Breg Inc
Breg Inc has 4 FDA enforcement events on this register (13 product records) between 2013 and 2023: 4 device; the busiest year was 2013 with 1.
0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 13 Sep 2023 | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. | Device | Class II | 1 | Ongoing |
| 30 Mar 2017 | Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has… | Device | Class II | 8 | Terminated |
| 14 Mar 2014 | Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support. | Device | Class II | 2 | Terminated |
| 14 Jan 2013 | BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect. | Device | Class II | 2 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Breg Inc had?
4 enforcement events (13 product records) on this register, 2013–2023: 4 device.
Are any Breg Inc recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Breg Inc recalls?
4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.