FDA Reports Ongoing Recall of Covidien V-Loc 90 Suture Devices

The FDA's enforcement report dated August 19, 2026, lists the Class II recall of V-Loc 90 Absorbable Wound Closure Devices as ongoing, citing a potential sterile barrier defect.

2 reports on this incident · first at Aug 26, 2026, 8:47 p.m. ET

By AI ReporterWritten Aug 26, 2026, 8:53 p.m. ET

The U.S. Food and Drug Administration's enforcement report for August 19, 2026, lists the recall of 's V-Loc 90 Absorbable Wound Closure Devices as (recall number ). The action, initiated June 24, 2026, was classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The recall covers 135,875 devices distributed nationwide and in dozens of countries, including Australia, Canada, Germany, Japan, and the United Kingdom. The reason given was that the product may contain a perforation or tear in the sterile barrier packaging, which could lead to biocontamination of the sterile sutures, potentially causing infection, loss of vision if used in ophthalmic procedures, or prolonged surgery. The FDA's enforcement report does not provide identifying codes for the affected devices. Consumers and facilities with affected devices should refer to the recall notice for identification codes.

Earlier reports

Aug 26, 2026, 8:47 p.m. ETFirst report
Covidien Recalls V-Loc 90 Suture Devices Over Sterile Barrier Defects
Covidien, LP of North Haven, Connecticut, is recalling 135,875 V-Loc 90 Absorbable Wound Closure Devices, according to an FDA enforcement report dated August 19, 2026. The recall, initiated June 24, 2026, is classified as Class II and is ongoing.
The FDA report states the products may contain a perforation or tear in the sterile barrier packaging, which could lead to biocontamination of the sterile sutures, potentially causing infection, loss of vision if used in ophthalmic procedures, or prolonged surgery. The recall covers devices distributed nationwide and in many countries, including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, and the United Kingdom.
The V-Loc 90 is a barbed synthetic monofilament suture used by surgeons to join tissue without tying knots, according to the National Institutes of Health. The FDA defines Class II recalls as situations where the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The FDA database records no other enforcement action by this firm.
The recall notice does not provide specific lot numbers or model numbers for the affected devices. Consumers and healthcare providers are advised to contact Covidien for further information.

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Version 127 Aug 2026, 00:47current
First published.
Version 127 Aug 2026, 00:53current
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