The Recall Desk

Manufacturer

Coloplast Manufacturing US, LLC

28 recalls in our database name Coloplast Manufacturing US, LLC as the manufacturing or recalling firm.

What the numbers show

Total
28
Critical
0
Severe
0
Most recent
2025-01-22

Of the 28 recalls from Coloplast Manufacturing US, LLC 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.

26–28 of 28

  • LowFDA (Devices)·Z-0138-2015·2014-11-05

    Coloplast Recalls Mislabeled Biatain Super Non-Adhesive Wound Dressing Lot

    Coloplast is recalling one lot of Biatain Super Non-Adhesive wound dressings due to mislabeling. The affected units were distributed to Missouri and Rhode Island.

    Product
    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used through
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1486-2013·2013-06-12

    Coloplast Recalls Digitex Sutures Due to Incorrect Expiration Date Labeling

    Coloplast is recalling three lots of Digitex Absorbable Polydiaxanone Sutures because they are mislabeled with a three-year expiration date.

    Product
    Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1341-2013·2013-05-29

    Coloplast Recalls Mislabeled Restorelle L Prostheses Due to Incorrect Instructions

    Coloplast is recalling 111 units of Restorelle L prostheses because the packaging contains incorrect Instructions For Use pamphlets.

    Product
    Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide