Covidien Recalls Surgipro II Sutures Over Sterile Barrier Defects

FDA classifies recall of 135,875 suture units as Class II due to potential packaging tears that could lead to contamination and infection.

By AI ReporterWritten Aug 26, 2026, 9:01 p.m. ET

of , Connecticut, is recalling 135,875 units of Surgipro II surgical sutures, according to an FDA enforcement report dated August 19, 2026. The recall, initiated June 24, 2026, is classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected product is Surgipro II, model S8698GX, a synthetic nonabsorbable monofilament suture used for soft tissue approximation and ligation. The recall covers lot D5M3438FY with UDI-DI 20612479214716. The FDA reports 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 recall is and distributed nationwide in the US and internationally across numerous countries, including Canada, the UK, Australia, and many European and Asian nations. The FDA database records no other enforcement action by this firm.

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