The Recall Desk

FDA (Devices) recall action 92843

ETHICON, LLC recalled 2 products on 2023-09-27

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2023-09-27
Critical
0
Units
1,736,726

Why these products were recalled

Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

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.

1–2 of 2

  • HighFDA (Devices)··2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-09-27

    PDS II Surgical Sutures Recalled for Tensile Strength Defect

    ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

    Product
    PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
    Category
    Distribution
    0 states