Merit Medical recalls

The implantable clip in Merit Medical's Scout MD Delivery System may not deploy properly during surgery. This could prevent the reflector from working as intended to guide the surgical procedure.

Moderate·FDA·Oct 21, 2026

Merit Medical Systems is recalling Embosphere microspheres used in tumor and blood vessel procedures. Some units have holes in their packaging that could compromise the sterile barrier, potentially exposing the product to contamination and increasing infection risk if used.

Moderate·FDA·Oct 7, 2026

Merit Medical Systems' Splashwire Hydrophilic Guide Wire — used by doctors in vascular procedures — has been recalled because some product pouches were not sealed properly. Unsealed pouches can allow contamination or damage to the sterile device before use.

Moderate·FDA·Jun 24, 2026

Merit Medical is recalling five products, including CentrosFLO and DuraMax dialysis catheters and 16F dual valved splittable sheath introducers. The sheath introducer may not split as intended, which can cause bleeding, pieces left in the body, procedure delays, or blood clots. No injuries have been reported.

Serious·FDA·Apr 1, 20265 products

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

Moderate·FDA·Jan 28, 20267 products

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

FDA·Nov 26, 2025