The Recall Desk

FDA (Devices) recall action 82909

Ethicon, Inc. recalled 2 products on 2019-06-26

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
2019-06-26
Critical
0
Units
1,332

Why these products were recalled

Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2019-06-26

    Ethicon Recalls Polyester Sutures Due to Potential High Endotoxin Levels

    Ethicon, Inc. is recalling specific lots of ETHIBOND EXCEL polyester sutures because raw materials may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological proced
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2019-06-26

    Ethicon Recalls Ethibond Excel Polyester Sutures Due to Endotoxin Risk

    Ethicon, Inc. is recalling specific lots of Ethibond Excel polyester sutures because raw materials used in manufacturing may contain high endotoxin levels.

    Product
    ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedur
    Category
    Distribution
    5 states