The Recall Desk

FDA (Devices) recall action 84318

Allergan PLC recalled 4 products on 2019-12-25

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-12-25
Critical
0
Units
—

Why these products were recalled

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

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

States named across these recalls

1–4 of 4

  • LowFDA (Devices)··2019-12-25

    Allergan Natrelle Breast Implant Recall for Unreadable 2D Barcodes

    Allergan is recalling Natrelle saline-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline…
    Category
    Distribution
    47 states
  • LowFDA (Devices)··2019-12-25

    Allergan Recalls Natrelle Breast Implants Due to Unreadable 2D Barcodes

    Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel…
    Category
    Distribution
    47 states
  • LowFDA (Devices)··2019-12-25

    Allergan Recalls Breast Implant Sizers Due to Unreadable Barcodes

    Allergan is recalling NATRELLE Resterilizable Sizers because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch…
    Category
    Distribution
    47 states
  • LowFDA (Devices)··2019-12-25

    Allergan Recalls Breast Implants With Non-Standard 2D Barcodes

    Allergan is recalling Natrelle Inspira silicone-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US)…
    Category
    Distribution
    47 states