Z-0695-2019Class II

PROXIMATE HCS Hemorrhoidal Circular Stapler

Name: Z-0695-2019 PROXIMATE HCS Hemorrhoidal Circular Stapler
Creator: Ethicon Endo-Surgery Inc
Published: 2018-12-07
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2018-12-07 / Terminated / root cause: manufacturing process

FDA source

Ethicon Endo-Surgery Inc began a recall of PROXIMATE HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE HCS Hemorrhoidal Circular Stapler and Accessories have application for... on 2018-12-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0695-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-07
Posted: 2019-01-08
Terminated: 2020-04-29
Recalling firm: Ethicon Endo-Surgery Inc
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 musculomucosal tissue.
Product code: GDW Staple, Implantable
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Ethicon, issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to US consignees on 12/7/18, via UPS 2nd day mail. Ethicon Johnson & Johnson Affiliates in North America (Canada), Europe, LATAM, and Asia Pacific will notify their impacted consignees by providing the customer letter through post, email or sales representative visits. Letter identifies reason for recall, action to be taken: examine inventory and return recalled product for replacement; complete the Business Reply Form (BRF) confirming receipt of this notice and fax or email it to Stericycle at 1-844-524-3888 or [email protected] within three (3) business days. Please return the BRF even if you do not have the product lots subject to this recall.. Communicate the issue to relevant operating room or materials management personnel, or anyone else in the facility who needs to be informed. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Customers are required to return all PROXIMATE PPH Hemorrhoidal Circular Stapler products subject to this recall that are in their inventory immediately. To receive replacement product, customers must return product subject to this recall by April 1, 2019. Any unused Proximate PPH Hemorrhoidal Circular Stapler product lots subject to this recall returned after April 1, 2019 will not be eligible for replacement. Contact your Ethicon sales representative or contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). The Customer Support Center is open Monday through Friday, 7:30 AM to 6:30 PM ET
Quantity in commerce: 480 units
Distribution: 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.
Product codes and lots: Lot Codes: P9461W, P94K20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-08
Z-0696-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-08

Product code GDW

K030925Class IIProximate Hcs Hemorrhoidal Circular Stapler and Accessories, Model Pph01Ethicon Endo-Surgery, Inc. / cleared 2003-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)