Lower risk Medical device recall · FDA · Published November 10, 2020

Merit Medical Custom Inflation Kit Recall: Risk of Infection from Non-Sterile Devices

Merit Medical recalls custom angiography kits due to potential non-sterile devices causing infections. Affected kits may have compromised sterile barriers. Consumers should contact Merit Medical for details.

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

🇺🇸 FDA recall #Z-0749-2021Medical device Merit Medical Systems ›

Lower-risk recall

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical 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 custom angiography kits that may have compromised sterile barriers. This could lead to infections requiring medical treatment if non-sterile devices are used during procedures. Read more at govinfonow.com/recall/63942-merit-medical-custom-inflation-kit-recall-risk-of-infection-from.

Source Summary by GovInfoNow · govinfonow.com/recall/63942-merit-medical-custom-inflation-kit-recall-risk-of-infection-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0749-2021

Cite this page

“Merit Medical Custom Inflation Kit Recall: Risk of Infection from Non-Sterile Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63942-merit-medical-custom-inflation-kit-recall-risk-of-infection-from. Based on FDA recall #Z-0749-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2021%22&limit=1).

The FDA announced on November 10, 2020, that Merit Medical Systems, Inc. is recalling Custom Inflation Kits due to a compromised sterile barrier. The agency said the kits may contain header bags that are not fully sealed.

How to tell if you have it

Brand: Merit Medical Systems
Product Code: K05T-02533
Product Name: Custom Inflation Kit, Custom K05 Sterile EO, Rx Only
UPC: (01)00884450255803
Lot #: T1883210

The hazard

The FDA said the header bags in the angiography/angioplasty custom kits may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

Context

GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since 2006-02-24. Other recent recalls of similar products include Embosphere 500-700 Micrometer Syringe Recall (2026-08-10), Merit Medical Splashwire Hydrophilic Guide Wire Recall (2026-05-08), Philips Bridge Prep Kit Recall (2026-04-02), Medline Convenience Kits Recall (2026-06-12), AVID Medical Halyard IV Start Kit Non-Sterile Recall (2026-07-14), and Medline Convenience Kits Recall (2026-06-12).

How to tell if you have this one

Check for the product code K05T-02533 on the kit. The lot number T1883210 is associated with this recall. The kits are for angiography or angioplasty procedures.

Brand
Merit Medical Systems
Product
Merit Medical Systems, Inc. recalls Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For
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
US distribution to: KY, RI, and MD

Recall number	Product, codes & lots	Quantity
Z-0749-2021	Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze; (01)00884450255803 Lot # T1883210	90 kits
Z-0750-2021	Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze; (01)00884450339121 Lot # T1888031,	42 kits
Z-0751-2021	Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.; (01)00884450515105 Lot # T1907711,	80 kits

Based on the official FDA remedy

What to do — step by step

Contact Merit Medical
Reach out to Merit Medical Systems for specific instructions on how to handle the recalled kit.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “US distribution to: KY, RI, and MD” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Kentucky, Maryland, Rhode Island.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Nov 10, 2020Firm started the recall
Dec 29, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report
Oct 5, 2022FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/63942-merit-medical-custom-inflation-kit-recall-risk-of-infection-from">Merit Medical Custom Inflation Kit Recall: Risk of Infection from Non-Sterile Devices (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-0749-2021 (November 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0749-2021 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.