The Recall Desk

FDA (Devices) recall action 81773

Ethicon Endo-Surgery Inc recalled 2 products on 2019-01-16

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
2019-01-16
Critical
0
Units
15,744

Why these products were recalled

Hemorrhoidal Circular Stapler may have been assembled without a washer, this may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired

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)··2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Distribution
    0 states