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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

353

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 1621–1640 of 3680 recalls

PreludeSYNC Radial Compression (Merit Medical) – balloon failure (2020)

During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.

FDAMar 11, 2020AL, AZ, AR +30 more• Merit Medical Systems, Inc.

Rear Seatbelt CFR Retract (Key Safety Systems) – locking mechanism (2020)

Key Safety Systems, Inc. dba Joyson Safety Systems (Joyson) is recalling certain rear seat belt retractors equipped with a dual mode belt locking mechanism. Due to a manufacturing issue, the seat belt webbing locking mechanism may not properly restrain the occupant as intended.

NHTSAMar 6, 2020Nationwide• KEY SAFETY SYSTEMS

Infinix-8000V (Canon Medical) – table bolt issue (2020)

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

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FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

Western Star 4700 (Western Star) – brake caliper concern (2020)

Daimler Trucks North America LLC (DTNA) is recalling certain 2019-2020 Freightliner 108SD, 114SD, Cascadia, Business Class M2, Western Star 4700 and 5700, Freightliner Custom Chassis S2, Custom Chassis XB, and Custom Chassis XC vehicles equipped with air disc brakes. The brake caliper mounting bolts may have been insufficiently tightened.

NHTSAMar 3, 2020Nationwide• WESTERN STAR

Infinix-8000C (Canon Medical) – table bolt issue (2020)

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

Infinix-8000F (Canon Medical) – table bolt issue (2020)

Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.

FDAMar 3, 2020Nationwide• Canon Medical System, USA, INC.

Little Helper's Shopping Cart (Step2) – laceration risk (2020)

Laceration Risk

This recall involves Step2's Little Helper's Shopping Cart with the following model numbers and color combinations: 700000 (blue basket with tan cart,) 708500 (pink basket with white cart) and 8567KL (pink basket with gray cart). The grocery shopping carts measure 18.5 inches by 13 inches by 21.5 inches and have a shopping cart base and basket, four wheels and a doll seat. Only units with date code combinations of 5 and 19 are included in this recall. The date code can be found on the center rib on the back of the basket below the handle. The model number is located on the product packaging.

CPSCFeb 27, 2020Nationwide• The Step2 Company LLC, of Streetsboro, Ohio

DFINE Vertebral Assemblies (Merit Medical) – Incorrect Expiration Label (2020)

Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

FDAFeb 13, 2020Nationwide• Merit Medical Systems, Inc.

DFINE Vertebral Hydraulic Assemblies (Merit Medical) – incorrect expiration date (2020)

FDAFeb 13, 2020Nationwide• Merit Medical Systems, Inc.

Utilimaster Sprinter (Utilimaster) – rear camera issue (2020)

Spartan Motors USA (Spartan) is recalling certain 2019 Utilimaster Sprinter vehicles equipped with Voyager VOM74MM rear camera displays. The camera module power supply may fail, causing the rear view image display not to function.

NHTSAFeb 6, 2020Nationwide• UTILIMASTER

UST-2265-2 Probe (Hitachi) – inner cable miswiring (2020)

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

FDAJan 31, 2020CA, FL, GA +5 more• Hitachi Medical Systems America Inc

Lifeport Kidney Perfusion Transporter (Organ Recovery) – sample port leakage (2020)

Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

FDAJan 30, 2020Nationwide• Organ Recovery Systems, Inc.