Use caution Medical device recall · FDA · Published September 16, 2020

Merit Medical Cultura Flex Swab Recall: Flocked Tip Breaks Off Risk

Merit Medical recalls Cultura Flex Swab (Ref C100F) due to flocked tip breaking off during use, potentially causing soft tissue injury or treatment delays. Affected units sold before August 28, 2020.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0454-2021Medical device Merit Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416

✎ GovInfoNow plain-language explainer

Merit Medical is recalling their Cultura Flex Swab sterile collection device because its flocked tip might break off in the nasal passage during sample collection. This could cause soft tissue injury or delay medical treatment. The recall affects specific units sold before August 28, 2020. Read more at govinfonow.com/recall/64276-merit-medical-cultura-flex-swab-recall-flocked-tip-breaks-off.

Source Summary by GovInfoNow · govinfonow.com/recall/64276-merit-medical-cultura-flex-swab-recall-flocked-tip-breaks-off · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0454-2021

Cite this page

“Merit Medical Cultura Flex Swab Recall: Flocked Tip Breaks Off Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64276-merit-medical-cultura-flex-swab-recall-flocked-tip-breaks-off. Based on FDA recall #Z-0454-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0454-2021%22&limit=1).

The FDA announced on September 16, 2020, that Merit Medical Systems, Inc. is recalling the MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F. The flocked tip may break off during use, potentially causing soft tissue injury or delaying treatment.

How to tell if you have it

MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F
UPC 00884450491102 (1 unit)
UPC 10884450491109 (25 unit)
UPC 20884450491106 (100 unit)
Lots distributed prior to August 28, 2020

The hazard

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

Context

GovInfoNow's records show Merit Medical Systems, Inc. has had 37 other recalls on record since February 24, 2006. Other recent recalls include the Embosphere 500-700 Micrometer Syringe (August 10, 2026), the Merit Medical Splashwire Hydrophilic Guide Wire (May 8, 2026), and the Philips Bridge Prep Kit (April 2, 2026). Other recent recalls of similar products include the Medtronic Bio-Medicus Adult Cannula Kit (May 25, 2026), the Stryker BARD Dynamic Tip Steerable (April 10, 2026), and the B. Braun 21GA Winged Infusion Needle (February 2, 2026).

How to tell if you have this one

Check for the model number 'C100F' on the swab packaging. Units sold before August 28, 2020 are affected. The serial numbers listed in the recall notice include specific batch codes.

Brand
Merit Medical
Product
Merit Medical Systems, Inc. recalls MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.

Recall number	Product, codes & lots	Quantity
Z-0454-2021	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; All Lots distributed prior to August 28, 2020. 1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106	3,385,442 units
Z-0455-2021	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; All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127	159,396 units
Z-0456-2021	Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911; All Lots distributed prior to August 28, 2020. 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911	371,528 units

Based on the official FDA remedy

What to do — step by step

Check Swab Packaging
Look for the model number 'C100F' and serial numbers matching those listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

Sep 16, 2020Firm started the recall
Nov 16, 2020FDA classified it Class II
Nov 25, 2020Published in FDA’s Enforcement Report
Jun 1, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64276-merit-medical-cultura-flex-swab-recall-flocked-tip-breaks-off">Merit Medical Cultura Flex Swab Recall: Flocked Tip Breaks Off Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0454-2021 (September 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0454-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.