Agency classClass IIOur severity:High FDA (Devices)·Z-1528-2018·Announced 2018-05-02

EEA Hemorrhoid Stapler Recalled for Potential Welding Defect

FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies a risk of harm (bleeding or anastomotic leak) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling EEA Hemorrhoid and Prolapse Stapler Sets with DST Series Technology, 4.8MM, manufactured by Covidien LLC. The recall involves 475 units distributed worldwide, including in the United States and numerous foreign countries. The specific product number is HEM3348, and the affected lot numbers are N7K0694MX, N7L1078MX, and N7M0837MX.

The recall is issued because there is a potential for improper welding of the yellow staple guide to the instrument. If a device with an improperly welded staple guide is used, it may result in improper staple formation. This defect could potentially lead to bleeding or an anastomotic leak during or after the procedure.

The devices were distributed to healthcare facilities and providers in various U.S. states and international locations. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences. Users should contact the manufacturer or their supplier for further instructions on how to handle the affected devices.

The recalled product

Product: 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…
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Instruments
Hazard: bleeding
anastomotic-leak
manufacturing-defect
Affected units: 475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Lots: N7K0694MX
N7L1078MX
N7M0837MX

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Covidien LLC

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