The Recall Desk

Manufacturer

BioDerm, Inc.

3 recalls in our database name BioDerm, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2014-06-18

Of the 3 recalls from BioDerm, 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.

1–3 of 3

  • HighFDA (Devices)·Z-1744-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling specific skin wipes used in male incontinence devices due to potential bacterial contamination from a contract manufacturer.

    Product
    BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide