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RecallWatchMedical Device Safety
Class IIOngoingZ-1126-2026

Merit Medical Systems, Inc. recalls Merit Medical

Merit Medical Systems, Inc.South Jordan, UT, United StatesReported Jan 28, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Inflation device handle may detach from the syringe during procedure.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153K05T-03201
    394 affected lots
    00884450294918H280176800884450294918H287204500884450139325H261357300884450139325H2650871
    +386 more00884450139325H269718900884450139325H273653300884450139325H276797800884450139325H278795500884450139325H282389600884450139325H284489200884450139325H284910200884450139325H285478300884450139325H286480700884450139325H286982100884450139325H291109400884450139325H292049300884450139325H293757400884450139325H298077600884450139325H300622900884450139325H303011800884450139325H304174600884450139325H306829500884450139325H307789800884450139325H309616800884450139325H311555300884450139325H312511800884450139325H313659600884450139325H314793500884450139325H317911600884450139325H319115700884450139325H321539100884450139325H322769200884450139325H326608900884450139325H332482700884450141663H324807200884450141687H307996200884450141878H286735600884450141878H318352600884450139950H299440600884450140406H318353400884450298350H272596900884450756102I272553500884450756102I325446800884450286999T263652500884450286999T269734400884450286999T273035900884450286999T274522700884450286999T277973100884450286999T279225500884450286999T280545700884450286999T284225900884450286999T286549800884450286999T291641500884450286999T298146500884450286999T298590200884450286999T303994300884450286999T305487900884450286999T307160200884450286999T310583500884450286999T312875300884450286999T318548400884450286999T322324100884450286999T322963300884450286999T327696800884450286999T332812800884450286999T335629300884450140796T277464700884450140796T280097400884450140796T282338800884450140796T285348800884450140796T289914300884450140796T298146700884450140796T298776200884450140796T302209700884450140796T302210000884450140796T305838500884450140796T308300300884450140796T312158200884450140796T317412700884450140796T321449300884450140796T322945600884450140796T329751000884450140796T332454200884450315347T262581300884450315347T271863300884450315347T276271500884450315347T280545900884450315347T282339000884450315347T286378200884450315347T291071800884450315347T298147000884450315347T299766700884450315347T303604400884450315347T307077300884450315347T310882100884450315347T3149886S00884450315347T318553900884450315347T321449400884450315347T321670500884450315347T327691400884450315347T329609200884450315347T332813900884450142882T264355600884450142882T267557500884450142882T275294600884450142882T284226200884450142882T289387600884450142882T290605600884450142882T298147400884450142882T298776400884450142882T307081200884450142882T314617800884450142882T321608400884450142882T326900900884450142882T332276700884450142882T335629500884450260166T309391600884450260166T314867400884450260166T320404800884450260166T332276000884450140826T264355700884450140826T271960100884450140826T276533300884450140826T282339100884450140826T286145900884450140826T290993000884450140826T294561700884450140826T298590500884450140826T307095100884450140826T311145100884450140826T319081800884450140826T321449500884450140826T327874900884450140826T332284300884450140833T271687000884450140833T272691800884450140833T274525100884450140833T298335300884450140833T321602800884450095607T323233500884450095607T327145200884450095607T330668500884450684023T267557700884450684023T272691900884450684023T275959600884450684023T277465300884450684023T280097500884450684023T281044800884450684023T284325600884450814710T287152200884450814710T289865000884450814710T293278300884450814710T298597600884450814710T298776800884450814710T304383400884450814710T307160400884450814710T310583600884450814710T312655700884450814710T318554200884450814710T321449600884450814710T322945900884450814710T327696200884450814710T330986000884450814710T333946900884450255803T271863400884450255803T280972500884450255803T284921600884450255803T287692200884450255803T289905500884450255803T290993200884450255803T298149000884450255803T304247600884450255803T307160500884450255803T312341500884450255803T318120900884450255803T318543400884450255803T329321000884450255803T331547400884450255803T333607000884450463796T281627500884450463796T285076000884450463796T293999100884450463796T298598500884450463796T303331700884450463796T320246800884450547915T265602800884450547915T269035700884450547915T271863500884450547915T282339400884450547915T298325800884450547915T304490500884450547915T305490000884450547915T311316000884450547915T319081900884450547915T321602900884450547915T324529700884450547915T3328140

What the firm is doing

On December 4, 2025 Merit Medical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. Merit asked consignees to take the following actions: 1. Please read and understand the recall notification. 2. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast 3. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. Please fill out, scan, and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within seven (7) calendar days

DistributionShow details

Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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