Use caution Medical device recall · FDA · Published April 9, 2018

Covidien Hemorrhoid Stapler Set Recall: Risk of Improper Staple Formation

Covidien recalls hemorrhoid and prolapse stapler sets with DST Series Technology 3.5MM for potential improper staple formation causing bleeding or anastomotic leaks.

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

🇺🇸 FDA recall #Z-1527-2018Medical device Covidien ›

Use caution until it’s fixed

There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

Take action

Contact the company

Recalling firmCovidien LLC60 Middletown Ave · North Haven, CT 06473-3908

✎ GovInfoNow plain-language explainer

Covidien is recalling hemorrhoid and prolapse stapler sets with DST Series Technology 3.5MM (product number HEM3335) due to a risk of improper staple formation that could lead to bleeding or anastomotic leaks. This recall affects medical professionals using these devices during surgical procedures. Read more at govinfonow.com/recall/71488-covidien-hemorrhoid-stapler-set-recall-risk-of-improper-staple-formation.

Source Summary by GovInfoNow · govinfonow.com/recall/71488-covidien-hemorrhoid-stapler-set-recall-risk-of-improper-staple-formation · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1527-2018

Cite this page

“Covidien Hemorrhoid Stapler Set Recall: Risk of Improper Staple Formation.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71488-covidien-hemorrhoid-stapler-set-recall-risk-of-improper-staple-formation. Based on FDA recall #Z-1527-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1527-2018%22&limit=1).

The FDA announced on April 9, 2018, that Covidien LLC voluntarily recalled EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology. The agency cited a potential for improper welding of the staple guide, which could lead to bleeding or anastomotic leak.

How to tell if you have it

Brand: Covidien
Product: EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology 3.5MM
Product Number: HEM3335
GTIN Number 1: 10884521047518
GTIN Number 2: 20884521047515
Lots: N7J1145MX, N7L0380MX, N7L0762MX, N7L1077MX, N7M0733MX, N7K0092MX, N7L0457MX, N7L0868MX, N7M0144MX, N7M0835MX, N7K0692MX, N7L0594MX, N7L0940MX, N7M0185MX, N8A0144MX, N7K0693MX, N7L0676MX, N7L1076MX, N7M0732MX, N8A0166MX
Units affected: 5547

The hazard

The recall addresses the potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls of similar products include Covidien EndoFLIP System: Catheters May Be Incorrectly Flagged as Expired (May 13, 2026), Covidien Mon-a-Therm Stethoscope Recall: Unapproved Temperature Sensor Risk (April 23, 2026), and Covidien Shiley Disposable Decannulation Plug Recall: Incorrect DEHP Labeling (April 23, 2026). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue 75cm Sutures Recall: Risk of Infection from Packaging Tears (June 24, 2026), Covidien EndoStitch Polysorb Loading Unit Recall: Sterile Package Risk (April 15, 2026), and Covidien V-Loc 90 Wound Closure Device Recall: Risk of Infection from Damaged Packaging (June 24, 2026).

How to tell if you have this one

Check for the product number HEM3335 on the packaging or device. The recall includes specific lots listed in the record: N7J1145MX, N7L0380MX, N7L0762MX, and other lots starting with N7 or N8.

Brand
Covidien
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 in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA. The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Indonesia, Italy, Korea, Malaysia, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, UK, and Vietnam.

Recall number	Product, codes & lots	Quantity
Z-1527-2018	EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.; Lots: N7J1145MX, N7L0380MX, N7L0762MX, N7L1077MX, N7M0733MX,N7K0092MX, N7L0457MX, N7L0868MX, N7M0144MX, N7M0835MX, N7K0692MX, N7L0594MX, N7L0940MX, N7M0185MX N8A0144MX, N7K0693MX, N7L0676MX, N7L1076MX, N7M0732MX, N8A0166MX	5547
Z-1528-2018	EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed for use as a stapler instrument for control of rectal prolapse and hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST staples and removes a circular tissue specimen. The instrument is offered in a 33mm diameter size with either 3.5mm or 4.8mm staples. The accompanying accessories comprised of an access port, anoscope, and dilator. The access port aids the insertion and removal of the anoscope and the stapler device by dilating the anal sphincter throughout the procedure. The anoscope is designed to facilitate pursestring suture application above the dentate line. It is designed with a guide and markings to assist in creating a circumferential pursestring suture at a consistent placement within the rectum. The dilator is designed to aid the initial insertion of the anoscope and port by retracting the rectal tissue. Both the anoscope and port are transparent to facilitate visualization of the anal canal. The EEA Hemorrhoid and prolapse stapler set with DST Series Technology has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease. The EEA Hemorrhoid and prolapse stapler also has application in the distal alimentary tract for the creation of end-to-end and end-to-side anastomoses.; Lots: N7K0694MX, N7L1078MX, N7M0837MX	475

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot numbers N7J1145MX, N7L0380MX, N7L0762MX, or other listed lots on the packaging or device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 27 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA. The devices were distributed to the following foreign countries:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Apr 9, 2018Firm started the recall
Apr 26, 2018FDA classified it Class II
May 2, 2018Published in FDA’s Enforcement Report
May 12, 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/71488-covidien-hemorrhoid-stapler-set-recall-risk-of-improper-staple-formation">Covidien Hemorrhoid Stapler Set Recall: Risk of Improper Staple Formation (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-1527-2018 (April 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1527-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.