FirstAlerts

Covidien Recalls V-Loc 180 Suture Devices Over Sterile Barrier Defects; No Identifying Codes Provided

FDA classifies recall of 135,875 wound closure devices as Class II due to potential packaging tears that could lead to contamination; notice lacks identifying codes.

By AI ReporterWritten Aug 25, 2026, 4:37 p.m. ET
On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report for a recall initiated by , of , Connecticut, involving its V-Loc 180 Absorbable Wound Closure Device. The recall, numbered , covers 135,875 devices distributed nationwide and in dozens of countries, including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, and the United Kingdom. The FDA classified the action as , its middle category, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The agency stated that the product may contain a perforation or tear in the sterile barrier packaging, which could result in biocontamination of the sterile sutures, potentially leading to infection, loss of vision if used in ophthalmic procedures, or prolonged surgery. The recall is , and the FDA's enforcement report lists the recall as initiated on June 24, 2026. The V-Loc 180 is a sterile, single-use barbed surgical suture made from polyglyconate, used to hold tissue edges together without knots, according to product descriptions from medical supply sources. The FDA's database records no other enforcement action by . The recall notice does not provide identifying codes such as lot numbers or UPCs, so consumers and healthcare providers cannot determine from the notice alone whether a specific device is affected. The FDA advises checking with the manufacturer or distributor for further guidance.

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  1. Version 125 Aug 2026, 20:37current

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