Agency classClass IIOur severity:High FDA (Devices)·Z-2919-2026·Announced 2026-08-19

V-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects

FDA is recalling V-Loc 180 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that could lead to biocontamination.

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 is classified as FDA Class II, and the hazard involves potential biocontamination leading to infection, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling the V-Loc 180 Absorbable Wound Closure Device manufactured by Covidien, LP. The recall is due to a potential defect where the sterile barrier packaging may contain a perforation or tear. This issue could result in the biocontamination of the sterile sutures.

The affected products include various V-Loc 180 Absorbable Wound Closure Device configurations and associated surgical kits. The recall covers 135,875 units distributed nationwide in the United States and in numerous countries across Europe, Asia, the Americas, and other regions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI-DI codes listed in the official recall notice. If the product is found, it should be quarantined and not used. Patients who have already received these devices should contact their healthcare provider if they experience signs of infection or other complications.

The recalled product

Product: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003…
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: infection
packaging-defect
Affected units: 135,875

Distribution

Distributed nationwide across the United States.

Same manufacturer · Covidien, LP

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Same hazard · infection