The Recall Desk

FDA (Devices) recall action 86826

Medline Industries Inc recalled 5 products on 2021-01-13

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2021-01-13
Critical
0
Units
623

Why these products were recalled

The cylindrical sponge component is not x-ray detectable.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··2021-01-13

    Medline Recalls Non-X-Ray Detectable Surgical Sponges in Convenience Kits

    Medline Industries is recalling 88 surgical convenience kits because the cylindrical sponge component is not x-ray detectable. The affected products were distributed only in Canada.

    Product
    Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-13

    Medline Cardiac Pack Recall for Non-X-Ray Detectable Sponge Component

    Medline Industries is recalling Cardiac Pack - LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only in Canada.

    Product
    Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-13

    Medline Thyroid Pack Recall Due to Non-X-Ray Detectable Sponge

    Medline Industries is recalling 40 Thyroid Pack CKHA-LF kits because the cylindrical sponge component is not x-ray detectable. The affected units were distributed only to Canada.

    Product
    Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-13

    Medline Aortic Graft Kits Recalled for Non-Detectable Sponge Component

    Medline Industries is recalling 45 aortic graft kits in Canada because the included sponge is not x-ray detectable.

    Product
    Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-13

    Medline Simple Neck Dissection Kit Recalled for Non-X-Ray Detectable Sponge

    Medline Industries is recalling 90 units of Simple Neck Dissection kits because the cylindrical sponge component is not x-ray detectable.

    Product
    Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
    Category
    Distribution
    0 states