Agency classClass IIOur severity:Severe FDA (Devices)·Z-1827-2019·Announced 2019-06-26

FDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices

The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that 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 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) has issued a Class II recall for 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu, Item Code EGIA45AXT, manufactured by Covidien LLC. The recall is due to a defect where 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. Incomplete stapling may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis. The affected devices were distributed nationwide in the United States and worldwide in foreign markets.

The recall number is Z-1827-2019. The source text does not specify specific lot numbers or dates, but identifies the product by the item code EGIA45AXT. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
Manufacturer: Covidien LLC
Category: Medical Device — Surgical Stapler
Hazard: structural-defect
bleeding
infection
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)

N6B0080KX N6C0975KX

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

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · structural defect