Ethicon Endo-Surgery Inc: Medical Device Recall in 2019 - (Recall #: Z-0695-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 musculomucosal tissue.

Product Classification:

Class II

Date Initiated: December 7, 2018

Date Posted: January 16, 2019

Recall Number: Z-0695-2019

Event ID: 81773

Reason for Recall:

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

Status: Terminated

Product Quantity: 480 units

Code Information:

Lot Codes: P9461W, P94K20

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and to countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, ECUADOR, EGYPT, INDIA, INDONESIA, JAPAN, KOREA, KUWAIT, LEBANON MEXICO, NICARAGUA, PAKISTAN, SAUDI ARABIA, SINGAPORE, TAIWAN URUGUAY and VIETNAM.

Voluntary or Mandated:

Voluntary: Firm initiated