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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Merit Medical Systems, Inc.: Microcatheter and Infusion Systems Recalled for Lack of Sterility Assurance

Agency Publication Date: January 2, 2024
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Summary

Merit Medical Systems is recalling approximately 779 units of Merit Maestro, Merit Pursue microcatheters, and Fountain infusion systems because their sterility cannot be guaranteed. Using a non-sterile medical device during a procedure can lead to serious infections or other health complications for patients. These devices were distributed across the United States and multiple international countries between late 2023 and early 2024. Consumers and healthcare providers should identify these products by their specific reference and lot numbers and contact the manufacturer for further instructions.

Risk

The manufacturer cannot guarantee the sterility of these internal medical devices, which are used in vascular and infusion procedures. If a device that is not sterile is introduced into a patient's body, it poses a significant risk of causing local or systemic infections, which may require additional medical treatment.

What You Should Do

  1. Immediately check your inventory for Merit Maestro Microcatheters with reference numbers such as 28MC2111045/B, 28MC24130ST/D, or 29MC29150ST/D, and lot numbers including H2775120, H2750697, and H2750699.
  2. Check for Merit Pursue Microcatheters with reference numbers 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, or 29HC20150ST and lot numbers H2769793, H2767389, H2750582, H2750587, or H2765980.
  3. Identify Fountain Infusion Systems with reference numbers IS4-135-30 (Lot H2765720) or IS4-90-10 (Lot H2765603).
  4. Stop using all affected products immediately and quarantine them to prevent accidental use in medical procedures.
  5. Contact your healthcare provider or Merit Medical Systems at 1600 W Merit Pkwy, South Jordan, Utah, 84095-2416 for specific instructions on returning the product and obtaining a potential refund or replacement.
  6. For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Merit Maestro Microcatheter
Model / REF:
28MC2111045/B
28MC21110ST/B
28MC2113045/B
28MC21130SN/CNB
28MC21130ST/B
28MC2115045/B
28MC2115045/C
28MC21150SN/B
28MC21150ST/B
28MC2411045/D
28MC24110SN/D
28MC24110ST/D
28MC2413045/D
28MC24130SN/F
28MC24130ST/D
28MC24130ST-W/A
28MC2415045/D
28MC24150ST/D
28MC24150ST/F
28MC28110ST/D
28MC2813045/D
28MC28130SN/D
28MC28130SN/F
28MC28130ST/D
28MC28150SN/D
28MC28150SN/F
29MC2911045/D
29MC29130SN/F
29MC29130ST/D
29MC29150ST/CNB
29MC29150ST/D
UPC Codes:
00884450335215
00884450335239
00884450335246
00884450335253
00884450335260
00884450335277
00884450442456
00884450335284
00884450335291
00884450357903
00884450357910
00884450357927
00884450357934
00884450358207
00884450357958
00884450324592
00884450357965
00884450357989
00884450358245
00884450358016
00884450358023
00884450358030
00884450358290
00884450358047
00884450358320
00884450358085
00884450358382
00884450358139
00884450038383
00884450358160
Lot Numbers:
H2775120
H2750697
H2775121
H2750699
H2763805
H2775122
H2747446
H2750708
H2750484
H2750714
H2750715
H2769214
H2750719
H2750721
H2769962
H2750518
H2750733
H2766010
H2750372
H2750747
H2779460
H2777603
H2750756
H2766011
H2769993
H2750768
H2749681
H2770003
H2770016
H2770029
H2785162
H2750378
H2752481
H2766013
H2756905
H2765969
H2750387
H2758290
H2750390
H2750599
H2756603
H2749336
H2765976
H2770087
Product: Merit Pursue Microcatheter
Model / REF:
28HC17130SN
28HC17150ST/A
29HC2015045/A
29HC20150SN/A
29HC20150ST
UPC Codes:
00884450315453
00884450358566
00884450358726
00884450358733
00884450315408
Lot Numbers:
H2769793
H2767389
H2750582
H2750587
H2765980
Product: Fountain Infusion System
Model / REF:
IS4-135-30
IS4-90-10
UPC Codes:
00884450000885
00884450006504
Lot Numbers:
H2765720
H2765603

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93461
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 3 products (717 units; 59 units; 3 units)
Distributed To: Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.