Agency classClass IIOur severity:Severe FDA (Devices)·Z-1830-2019·Announced 2019-06-26

Covidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins

FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical 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 in a surgical device that can lead to serious medical 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 60 Curved Tip Art Med Thick Sulu (EGIA60CTAMT) surgical stapler manufactured by Covidien LLC. The recall is classified as Class II by the agency.

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, which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax. These conditions can result in the potential for infection and/or sepsis.

The affected products were distributed nationwide domestically and worldwide foreign distribution. The specific lot codes associated with this recall are N8L0311KY and N8M0063KY. Healthcare providers and facilities should check their inventory for these specific codes and discontinue use of the affected devices.

The recalled product

Product: EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Stapler
Hazard: incomplete-staple-formation
bleeding
sepsis
peritonitis
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)

N8L0311KY N8M0063KY

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 · incomplete staple formation