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FDA Expands Covidien V-Loc 90 Suture Recall to Include Additional Sizes

The recall now covers 4-0, 3-0, 2-0, and 0 sizes in lengths from 15 to 45 centimeters, according to the FDA enforcement report.

5 reports on this incident · first at Aug 25, 2026, 4:37 p.m. ET

By AI ReporterFirst reported Aug 26, 2026, 5:40 p.m. ETWritten Aug 26, 2026, 6:11 p.m. ET
The U.S. Food and Drug Administration has expanded its recall of 's , to include additional sizes. The recall, identified as , now covers sutures in sizes 4-0, 3-0, 2-0, and 0, in lengths from 15 to 45 centimeters, according to the FDA enforcement report dated Aug. 19, 2026. The recall was initiated July 1, 2026, because , which could lead to biocontamination of the sterile sutures. This could result in infection, loss of vision if used in ophthalmic applications, or prolonged surgery, according to Medical Daily. The FDA has classified this as a Class II recall, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per the FDA's recall definitions. The recall affects distributed nationwide in the U.S. and in roughly 60 other countries and territories, including Canada, Mexico, Chile, Colombia, Guatemala, the United Kingdom, Germany, France, Japan, India, South Korea, China, and much of the Middle East, according to Medical Daily. , based in , CT, is the firm responsible for the recall. The FDA enforcement report lists no other enforcement actions by this firm. The remedy instructs users to immediately identify, cease use, and quarantine all unused affected product and return it to Medtronic, according to Medical Daily.

Earlier reports

  1. Aug 26, 2026, 6:05 p.m. ET

    FDA Reclassifies Covidien V-Loc 90 Suture Recall as Class II

    The U.S. Food and Drug Administration has reclassified the recall of Covidien's V-Loc 90 Absorbable Wound Closure Device as Class II, according to an FDA enforcement report dated Aug. 19, 2026. The agency defines Class II as a situation where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote.

    The recall, initiated July 1, 2026, covers 135,875 units of the barbed surgical suture in sizes 4-0, 3-0, 2-0, and 0, ranging from 15 to 45 centimeters. The reason for the recall is that the sterile barrier packaging may contain a perforation or tear, which could lead to biocontamination of the sutures. This could result in infection, loss of vision if used in ophthalmic applications, or prolonged surgery, according to Medical Daily.

    The FDA recall record does not report any injuries associated with this action, and Health Canada's notice states that no complaints have been identified. The recall status is open. The FDA database records no other enforcement action by Covidien, the firm based in North Haven, Connecticut.

    The product is distributed nationwide in the U.S. and in roughly 60 other countries and territories, including Canada, Mexico, Chile, Colombia, Guatemala, the United Kingdom, Germany, France, Japan, India, South Korea, China, and much of the Middle East. The remedy directs users to immediately identify, cease use, and quarantine all unused affected product and return it to Medtronic.

  2. Aug 26, 2026, 6:01 p.m. ET

    FDA Reports Injuries in Covidien V-Loc 90 Suture Recall

    The U.S. Food and Drug Administration has reported injuries associated with the recall of Covidien's V-Loc 90 Absorbable Wound Closure Device, according to an FDA enforcement report dated Aug. 19, 2026. The report, identified by recall number Z-2919-2026, does not specify the number or nature of the injuries. Health Canada's notice states that no complaints have been identified.

    The recall, initiated July 1, 2026, covers 135,875 units of the barbed surgical suture distributed nationwide and in about 60 other countries. The FDA classified it as Class II, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The reason for the recall is a potential perforation or tear in the sterile barrier packaging, which could lead to biocontamination and, if used in ophthalmic applications, loss of vision.

    The affected product includes sizes 4-0, 3-0, 2-0, and 0, in lengths from 15 to 45 centimeters. The FDA advises users to immediately identify, cease use, and quarantine all unused affected product and return it to Medtronic. The recall status is open. The FDA database records no other enforcement action by this firm.

  3. Aug 26, 2026, 5:56 p.m. ET

    FDA Report Dated Aug. 19, 2026 Details Covidien V-Loc 90 Suture Recall Over Sterile Barrier Defects

    The U.S. Food and Drug Administration's enforcement report dated Aug. 19, 2026 (recall number Z-2919-2026) details the recall of Covidien's V-Loc 90 Absorbable Wound Closure Device, a barbed surgical suture. The action, initiated July 1, 2026, was classified as Class II, 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 units distributed nationwide and in about 60 other countries, including Canada, Mexico, the United Kingdom, Germany, France, Japan, India, and China. The affected product includes sizes 4-0, 3-0, 2-0, and 0, in lengths of 15 to 45 centimeters. The FDA record does not report any injuries, and Health Canada's notice states no complaints have been identified.

    The reason for the recall is a potential perforation or tear in the sterile barrier packaging, which could lead to biocontamination and, if used in ophthalmic applications, loss of vision or prolonged surgery. The remedy instructed users to immediately identify, cease use, and quarantine all unused affected product and return it to Medtronic. The FDA database records no other enforcement action by this firm.

  4. Aug 25, 2026, 4:37 p.m. ETFirst report

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

    On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report for a recall initiated by Covidien, LP, of North Haven, Connecticut, involving its V-Loc 180 Absorbable Wound Closure Device. The recall, numbered Z-2919-2026, 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 Class II, 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 ongoing, 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 Covidien, LP.

    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 126 Aug 2026, 22:11current

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  2. Version 125 Aug 2026, 20:37current

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  4. Version 126 Aug 2026, 22:05current

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  5. Version 126 Aug 2026, 21:56current

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