The Recall Desk

Manufacturer

Breg Inc

13 recalls in our database name Breg Inc as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2023-11-15

Of the 13 recalls from Breg Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • HighFDA (Devices)·Z-0231-2024·2023-11-15

    Breg Folding Walkers With Wheels Recalled for Misaligned Wheels

    Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.

    Product
    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1901-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling sterile dressings (P/N 02328) because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    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 app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Rect L (P/N 02428) because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Rect L, P/N 02428 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2017·2017-05-10

    Breg Inc Recalls Dressing Back P/N 09810 Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Dressing Back P/N 09810 because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Back, P/N 09810 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 i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 sterile dressings because approximately 0.22% may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing M/U XL, P/N 02344 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1906-2017·2017-05-10

    Breg Inc Recalls Unsealed Sterile Dressings for Cold Therapy Pads

    Breg Inc is recalling approximately 2,609 sterile dressings used with cold therapy pads because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr XL, P/N 04918 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 appli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2017·2017-05-10

    Breg Recalls If Hip Sterile Polar Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of If Hip Sterile Polar Dressings because some may have unsealed pouches, rendering them non-sterile.

    Product
    If Hip, Sterile Polar Dressing P/N 10680 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1905-2017·2017-05-10

    Breg Inc Recalls Sterile Dressings Due to Potential Unsealed Pouches

    Breg Inc is recalling approximately 2,609 sterile dressings because a small percentage may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing Shldr, P/N 04908 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2017·2017-05-10

    Breg Inc Recalls Knee Dressings Due to Unsealed Pouches

    Breg Inc is recalling 2,609 units of Knee L/XL Dressings because some may have unsealed pouches, rendering them non-sterile.

    Product
    Dressing, Knee L/XL, P/N 04708 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 app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2014·2014-04-16

    Breg Recalls Knee Sleeves for Missing Latex Warning Labels

    Breg Inc is recalling specific knee sleeves because they contain latex but lack the required caution labels.

    Product
    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2014·2014-04-16

    Breg Recalls Knee Supports for Missing Latex Warning Labels

    Breg Inc is recalling two knee support models because they contain latex but lack the required caution label.

    Product
    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2013·2013-02-20

    Breg Cold Therapy Units Recalled for Potential Sterility Compromise

    Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2013·2013-02-20

    Breg Recalls Sterile Polar Pads Due to Packaging Damage

    Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.

    Product
    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide