Use caution Medical device recall · FDA · Published December 7, 2018

Ethicon PROXIMATE PPH Hemorrhoidal Stapler Recall: Risk of Bleeding During Use

Ethicon recalls PROXIMATE PPH Hemorrhoidal Circular Staplers with specific product codes due to potential bleeding or soft tissue injury from improper assembly. Affected units include certain lot codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0696-2019Medical device Ethicon ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803

✎ GovInfoNow plain-language explainer

Ethicon is recalling hemorrhoidal circular staplers that may have been assembled without a washer, which could cause bleeding or soft tissue injury during use. This recall affects specific product codes and lot numbers. Read more at govinfonow.com/recall/69372-ethicon-proximate-pph-hemorrhoidal-stapler-recall-risk-of-bleeding-during.

Source Summary by GovInfoNow · govinfonow.com/recall/69372-ethicon-proximate-pph-hemorrhoidal-stapler-recall-risk-of-bleeding-during · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0696-2019

Cite this page

“Ethicon PROXIMATE PPH Hemorrhoidal Stapler Recall: Risk of Bleeding During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69372-ethicon-proximate-pph-hemorrhoidal-stapler-recall-risk-of-bleeding-during. Based on FDA recall #Z-0696-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0696-2019%22&limit=1).

The FDA announced on 2018-12-07 that Ethicon Endo-Surgery Inc is recalling PROXIMATE PPH Hemorrhoidal Circular Staplers because they may have been assembled without a washer, potentially causing bleeding or soft tissue injury. The recall affects 15,264 units distributed worldwide.

How to tell if you have it

Brand: Ethicon
Product: PROXIMATE PPH Hemorrhoidal Circular Stapler
Product Code: PPH03
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

The hazard

According to the FDA, the hemorrhoidal circular stapler may have been assembled without a washer. This defect may potentially cause bleeding or soft tissue injury during use as the device may not fully cut when fired.

Context

GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since 2017-10-23. Other recent recalls include Ethicon ECHELON LINEAR Cutters Reload 80mm Blue (2025-09-11), Ethicon Endopath Echelon Vascular White Reload (2025-04-22), and Ethicon Endo-Surgery ECHELON 45mm Staple Reloads (2023-12-11). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (2026-03-03), Covidien V-Loc 180 Absorbable Wound Closure Device Recall (2026-06-24), and Oscor Abiomed Introducer Kit Recall (2026-06-10).

How to tell if you have this one

Check the product code (PPH03) and lot numbers listed in the recall notice. The affected units include specific lot codes such as P93K95, P9420Y, and others.

Brand
Ethicon
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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.

Recall number	Product, codes & lots	Quantity
Z-0695-2019	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.; Lot Codes: P9461W, P94K20	480 units
Z-0696-2019	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; 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	15,264 units

Based on the official FDA remedy

What to do — step by step

Check Product Code
Verify the product code is PPH03 and the lot number matches the listed codes.
Contact Manufacturer
Reach out to Ethicon Endo-Surgery for further assistance if you have the affected product.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Dec 7, 2018Firm started the recall
Jan 8, 2019FDA classified it Class II
Jan 16, 2019Published in FDA’s Enforcement Report
Apr 29, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/69372-ethicon-proximate-pph-hemorrhoidal-stapler-recall-risk-of-bleeding-during">Ethicon PROXIMATE PPH Hemorrhoidal Stapler Recall: Risk of Bleeding During Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0696-2019 (December 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0696-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.