Merit Medical Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0454-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

Product Classification:

Class II

Date Initiated: September 16, 2020

Date Posted: November 25, 2020

Recall Number: Z-0454-2021

Event ID: 86522

Reason for Recall:

The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

Status: Terminated

Product Quantity: 3,385,442 units

Code Information:

All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

Distribution Pattern:

Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.

Voluntary or Mandated:

Voluntary: Firm initiated