FDA Class II Recall Issued for Boston Scientific Transcarotid/Peripheral Access Kits

Galt Medical Corporation recalls 114,260 kits due to risk of black depth markings detaching from the sheath; no identifying codes provided in notice.

By AI ReporterWritten Aug 26, 2026, 9:11 p.m. ET

The U.S. Food and Drug Administration (FDA) announced a recall on August 19, 2026, for Boston Scientific Enhance Transcarotid/Peripheral Access Kits (REF: SR-4F21G7D-MP, Kit-075-03). The recall, initiated June 26, 2026, affects 114,260 kits distributed nationwide in Minnesota, according to the FDA enforcement report (recall number ). The reason for the recall is that black depth markings may detach from the outer sheath of the coaxial dilator introducer component. The FDA classifies this as , meaning the product may cause temporary or medically reversible harm, with a remote chance of serious harm, per the FDA's recall definitions. The kits are single-use, sterile, prescription-only medical devices used by healthcare professionals to insert catheters into the vascular system. The recall is . The FDA database records no other enforcement action by , the , Texas firm listed in the report. The recall notice does not provide identifying codes such as lot numbers or serial numbers for the affected kits. Consumers and healthcare providers with these kits should contact to determine if their product is affected.

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Version 127 Aug 2026, 01:11current
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