Agency classClass IIOur severity:Severe FDA (Devices)·Z-1384-2021·Announced 2021-04-21

Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

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 risk of significant injury, including bleeding, tissue trauma, and the need for open surgery, which aligns with the 'Severe' rubric criteria for significant injury reports or high-risk device defects.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 11,391 units of the Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short (Item Code: SIGSDS30CTV). The recall was initiated by the manufacturer, Covidien, LP, due to a potential failure of the device's safety interlock mechanism. This interlock is designed to prevent an empty single-use reload from being fired a second time.

If the safety interlock fails, an empty reload may be fired, causing the stapler to cut tissue without deploying staples. This malfunction can result in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open surgical procedure. The affected units were distributed worldwide, including nationwide in the United States and in specific countries in Europe, Asia, and South America.

Healthcare providers and facilities that have received these specific lot numbers should stop using the affected devices and contact the manufacturer for instructions on return or replacement. Patients who have undergone procedures using these devices should contact their healthcare provider if they experience complications such as bleeding or wound issues.

The recalled product

Product: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Staplers
Hazard: device-malfunction
tissue-trauma
bleeding

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Covidien, LP 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 3 products in this recall →

Same manufacturer · Covidien, LP

See all →

Severe
Surgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
Severe
Dermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
High
V-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
High
Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
High
V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19

Same hazard · device malfunction