MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk
Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria for potential soft tissue injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Cultura Flex Swab, a sterile flocked collection device. The recall covers 3,385,442 units distributed worldwide, including the United States, Australia, Canada, and other international locations. The affected lots are those distributed prior to August 28, 2020.
The recall is being issued because the flocked tip of the 100mm swab may break off in the nasopharyngeal cavity during sample collection. This defect could result in soft tissue injury of the nasopharyngeal cavity or a delay in treatment.
Healthcare providers and consumers should stop using the affected swabs and contact Merit Medical Systems for further instructions or a refund.
The recalled product
- Product
- 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
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 3,385,442
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All Lots distributed prior to August 28
- 2020. 1 unit - (01)00884450491102
- 25 unit - (01)10884450491109
- 100 unit - (01)20884450491106
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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