The Recall Desk

Manufacturer

BrosMed Medical Co.,Ltd.

1 recall in our database name BrosMed Medical Co.,Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2019-03-06

Of the 1 recalls from BrosMed Medical Co.,Ltd. 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-0963-2019·2019-03-06

    BrosMed Hermes NC PTA Balloon Catheter Recalled for Labeling Error

    BrosMed Medical Co., Ltd. is recalling 400 Hermes NC PTA Balloon Dilatation Catheters because the labels display incorrect, higher-rated burst pressure information.

    Product
    Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysi
    Category
    Medical Device
    Distribution
    1 state