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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)

127

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 1961–1980 of 25000 recalls

DiamondTOUCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Pasteurized Donor Human Milk (Mothers' Milk Bank) – Physical Contaminant (2024)

Potential physical contaminant

Class IIILow

FDAAug 18, 2024AL• Mothers' Milk Bank of Alabama

Streamline Dialog Bloodline (B Braun) - Connector Insertion Risk (2024)

Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal septum may not open fully enough to prevent restrictions to flow. may cause delays in therapy while clinicians are forced to switch to retrograde flow method

1...97 9899100 101...1250

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Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Streamline Fresenius Tubing (B Braun) - Connector Insertion Risk (2024)

Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Berkley Jensen Gazebos (BJ's Wholesale) – Injury Risk (2024)

This recall involves Berkley Jensen branded cedar hard-topped gazebos with model numbers A102008010, A102008100, A102011920, and A102011902. The gazebos measure about 10 feet by 12 feet, or 12 feet by 14 feet. They were sold in copper color, which may appear brown, or black; and with or without netting panels and tie-back bands. Only these models sold during the dates identified below are included in this recall.

High

CPSCAug 15, 2024Nationwide• Lypometal Sdn. Bhd., of Malaysia (Sunjoy Group)

SL Bloodline for FMC (B Braun) - Connector Insertion Risk (2024)

Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Lidocaine HCl Injection (Fagron) – Sterility Concern (2024)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 15, 2024Nationwide• Fagron Compounding Services

Streamline Long Tubing (B Braun) - Connector Insertion Risk (2024)

Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Streamline Bloodline Long (B Braun) - Connector Insertion Risk (2024)

Moderate

FDAAug 15, 2024Nationwide• B Braun Medical Inc

Tegaderm CHG (3M) - Foreign Substance Contamination (2024)

Contamination with foreign substance matter

Moderate

FDAAug 14, 2024Nationwide• 3M Company Health Care Business 3m Center

Soltive Pro Laser (Olympus) - Translation Error (2024)

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

High

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Soltive Premium Laser (Olympus) - Translation Error (2024)

Moderate

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Seer Home EEG System (Seer Medical) - EMC Assessment Gap (2024)

During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies

High

FDAAug 12, 2024Nationwide• SEER MEDICAL PTY LTD 278-284 Queensberry St Melbourne Australia

Prelude Sheath Introducer (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

Moderate

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

BD FACSDuet Preparation System (BD) - Sample Dispensing Error (2024)

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

Moderate

FDAAug 12, 2024AK, CA, ID +10 more• Becton, Dickinson and Company, BD Bio Sciences

Custom Procedure Kit (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

Moderate

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

ViewPoint Imaging System (GE Healthcare) - Cybersecurity Vulnerability (2024)

The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.

High

FDAAug 8, 2024Nationwide• GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany

Anesthesia Extension Set (B. Braun) - Connector Leakage Risk (2024)

Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.

Moderate

FDAAug 8, 2024Nationwide• B. Braun Medical, Inc.

Philips Allura Xper System (Philips) - Bolt Placement Error (2024)

A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

Moderate

FDAAug 8, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Finger-Ease Guitar Lubricants (Chem-Pak) – Skin Irritation (2024)

This recall involves one production batch of Finger-Ease Guitar String Lubricant. The product is a clear aerosol spray sold in a white-color steel can with a black cap. The product measures about 1.5 inches long, 1.5 inches wide and 6 inches tall, and weighs about 4.5 ounces. The product has a picture of a brown guitar with the words "Tone Finger Ease Guitar String Lubricant" in brown, black and red lettering. There is a red horizontal stripe on the can. Printed on the can is "Manufactured by Chem-Pak, Inc.", and the production batch code is printed in black ink on the bottom of the steel container with model number 220B and lot code 106824.

Moderate

CPSCAug 8, 2024Nationwide• Chem-Pak Inc., of Martinsburg, West Virginia