Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect
Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.
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 involves a medical device with a defect that may lead to bleeding or anastomotic leak, which are significant surgical complications. The source text describes the risk as 'potential' and does not report any confirmed injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien LLC is recalling 5,547 units of the EEA Hemorrhoid and Prolapse Stapler Set with DST Series Technology 3.5MM (Product Number HEM3335). The recall involves specific lot numbers, including N7J1145MX, N7L0380MX, and N7L0762MX, among others. The devices were distributed worldwide, including across the United States and in numerous foreign countries such as Australia, Canada, Germany, and the United Kingdom.
The recall was initiated due to 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 can potentially lead to bleeding or anastomotic leak during surgical procedures.
The EEA Hemorrhoid and Prolapse Stapler Set is a medical device designed for the surgical treatment of hemorrhoidal disease and rectal prolapse. It is also used in the distal alimentary tract for creating anastomoses. Healthcare providers and facilities that have received these devices should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Covidien LLC
- Affected units
- 5,547
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 (19)
- Lots: N7J1145MX
- N7L0380MX
- N7L0762MX
- N7L1077MX
- N7M0733MX
- N7K0092MX
- N7L0457MX
- N7L0868MX
- N7M0144MX
- N7M0835MX
- N7K0692MX
- N7L0594MX
- N7L0940MX
- N7M0185MX N8A0144MX
- N7K0693MX
- N7L0676MX
- N7L1076MX
- N7M0732MX
- N8A0166MX
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.
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