Agency classClass IIOur severity:Severe FDA (Devices)·Z-1825-2019·Announced 2019-06-26

FDA Recalls Covidien EGIA 30 Articulating Medical Devices

The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that can lead to serious surgical complications such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 3,113,280 units of the EGIA 30 Articulating Medical Thick Sulu device, Item Code EGIA30AMT, manufactured by Covidien LLC. The recall is classified as Class II by the agency.

The recall is being issued because the device may be missing one of two pin components that maintain the alignment of the device jaws. This defect can result in incomplete staple formation during use, which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax. These conditions can result in the potential for infection and/or sepsis.

The affected lots are N5A0871KX, N7A0527KX, N7E0441KX, N8J0039KX, N8J0527KX, and N8J0820KX. The devices were distributed nationwide domestically and worldwide to foreign markets. Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Stapler
Hazard: structural-defect
incomplete-staple-formation
bleeding
sepsis
Affected units: 3,113,280

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 (1)

lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 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 12 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · structural defect