The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0455-2021·Announced 2020-11-25

Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk

Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.

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 Class II medical device with a documented potential for soft tissue injury if the swab tip breaks off during use. Per the severity rubric, Class II devices with risk-of-harm products where injury has not yet been reported qualify for a High severity rating.

Plain-English summary

The FDA is recalling the Merit Medical Cultura Collection and Transport System (Ref CFTS100) due to a safety concern identified during testing. The recall centers on the flocked tip of the 100mm swab, which may break off inside the nasopharyngeal cavity when collecting samples. This could result in soft tissue injury to the nasopharyngeal cavity or delay necessary treatment.

Consumers who have received or are receiving this single-use IVD system should stop using the product immediately and return it to their healthcare provider or authorized distributor for proper disposal. The manufacturer, Merit Medical Systems, Inc., issued recall number Z-0455-2021 for approximately 159,396 units distributed globally, including the United States.

The agency determined this is a Class II device recall involving a potential medical harm (soft tissue injury) that has not yet resulted in confirmed injuries or fatalities. Affected individuals should contact their healthcare facility or the manufacturer to arrange safe return of the product.

The recalled product

Product
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Collection System
Hazard
Affected units
159,396

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)00884450492123
  • 50 Units - (01)10884450492120
  • 200 units - (01)20884450492127

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · soft tissue injury

See all →

Similar recalls