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Merit Medical Systems, Inc.

Merit Medical Systems, Inc. Recalls

All product recalls associated with Merit Medical Systems, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3181–3200 of 21320 recalls

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Hydrocortisone Acetic Acid Otic Solution (Taro) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class IIILow

FDANov 6, 2023Nationwide• Taro Pharmaceuticals Inc.

Vitrakvi Oral Solution (Bayer) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing

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Class I

High

FDANov 6, 2023Nationwide• Bayer Healthcare Pharmaceuticals Inc.

ENDOEYE HD II Videoscope (Olympus) – image coloration (2023)

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

Moderate

FDANov 6, 2023Nationwide• Olympus Corporation of the Americas

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Moderate

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

Allura Systems (Philips) – ceiling mount collision risk (2023)

Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Medical Drainage Bag (Remington) – label date error (2023)

There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.

Low

FDANov 3, 2023FL, PA• Remington Medical, Inc.

Quantum Biliary Balloon Dilator (Wilson-Cook) – device nonconformity (2023)

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

Moderate

FDANov 3, 2023Nationwide• Wilson-Cook Medical Inc.

Multi-Mode Stimulator (Liberty Medical) – incomplete warnings (2023)

The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.

Low

FDANov 3, 2023Nationwide• Liberty Medical Solutions, LLC

LINQ II Cardiac Monitor (Medtronic) – signal interference (2023)

It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

Moderate

FDANov 3, 2023PR• Medtronic Inc.

Azurion Systems (Philips) – ceiling mount collision risk (2023)

Moderate

FDANov 3, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

AFTERBURN Whey Protein Bar (Doctors Scienfic Organica) – foreign material (2023)

Foreign material including disposable hairnet, shrink wrap and parchment paper.

Class IIModerate

FDANov 3, 2023Nationwide• Doctors Scienfic Organica

Sperm Separation Media (Fujifilm) – component mismatch (2023)

The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).

Low

FDANov 2, 2023AR, CA, FL +19 more• Fujifilm Irvine Scientific, Inc.

Oasis Drain (Atrium) – premature aging (2023)

A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

Moderate

FDANov 1, 2023Nationwide• Atrium Medical Corporation

Infusomat Administration Sets (B. Braun) – tubing inconsistency (2023)

In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

High

FDANov 1, 2023Nationwide• B. Braun Medical, Inc.

ELISA Parvovirus B19 IgM Test (Zeus) – conjugate modification (2023)

The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.

Moderate

FDAOct 31, 2023CA, MA, MI +4 more• Zeus Scientific, Inc.

ELISA Parvovirus B19 IgG Test (Zeus) – conjugate modification (2023)

The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.

Moderate

FDAOct 31, 2023CA, MA, MI +4 more• Zeus Scientific, Inc.

Lubricating Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lubricating Tears Eye Drops (Major) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class IHigh

FDAOct 31, 2023Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Flexible Patient Circuit (Vyaire) – unapproved distribution (2023)

Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Low

FDAOct 27, 2023FL• Vyaire Medical