The Recall Desk

Manufacturer

Breg Inc, An Orthofix Company

1 recall in our database name Breg Inc, An Orthofix Company as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2012-09-12

Of the 1 recalls from Breg Inc, An Orthofix Company 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.

1–1 of 1

  • ModerateFDA (Devices)·Z-2326-2012·2012-09-12

    Breg Polar Dressing Recalled for Thickness and Durability Defects

    Breg Inc. is recalling Polar Dressing units that are thinner than specified, making them less durable and prone to tearing.

    Product
    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide