Reported Jan 16, 2019 · Terminated

PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler…

Ethicon Endo-Surgery Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803

Is this the product you have?

  • PROXIMATE¿ PPH Hemorrhoidal
  • Circular Stapler Product CodePPH03
  • PPH03The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
Lot codes and dates
  • Lot Codes
    • P93K95
    • P9420Y
    • P94A4T
    • P93L1M
    • P9420Z
    • P94D3N
    • P93M3G
    • P9441H
    • P94F3Z
    • P93T35
    • P9450L
    • P94G04
    • P93T7F
    • P9463J
    • P94H5F
    • P93W3M
    • P94765
    • P94J4W
    • P93W3N
    • P9487Z
    • P94J80
    • P93Y58
    • P94901
    • P94K2A
    • P94117
    • P94A20
    • R9200Z
Amount recalled
15,264 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was 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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 29, 2020 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.