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.
What this means for you
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 f
- Manufacturer
- Covidien LLC
- 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
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 →Related recalls
Same manufacturer · Covidien LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Same hazard · bleeding
See all →- HighHollister Recalls Onli Hydrophilic Urethral Catheters Due to Manufacturing Defect
FDA (Devices) · 2026-09-02
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20
- SevereArrow-Clark VectorFlow Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereNextStep Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- SevereArrow Edge hemodialysis kits contain a sheath introducer that may not split
FDA (Devices) · 2026-05-20