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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

581

Class I (Serious)

Most Recent

Dec 2025

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 1881–1900 of 10937 recalls

COBRA-OS Sheath Introducer (Merit Medical) – incorrect needle size (2023)

Custom sheath Introducer contains incorrect needle size

Low

FDAMar 21, 2023MN• Merit Medical Systems, Inc.

Medtronic SenSight Tunneler Kit (Medtronic) – carrier machining issue (2023)

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

Moderate

FDAMar 17, 2023Nationwide• Medtronic Neuromodulation

Kagome Worcester Sauce (Mutual Trading) – Undeclared Soy (2023)

Undeclared Allergen

Undeclared allergen; soy.

Class IHigh

1...93 949596 97...547

Page 95 of 547Next

FDA

Mar 17, 2023

AZ, CA, HI +3 more

• Mutual Trading Company Inc.

Kagome Chuno Sauce (Mutual Trading) – Undeclared Soy (2023)

Undeclared Allergen

Undeclared allergen; soy.

Class IHigh

FDAMar 17, 2023AZ, CA, HI +3 more• Mutual Trading Company Inc.

Kagome Tonkatsu Sauce (Mutual Trading) – Undeclared Soy (2023)

Undeclared Allergen

Undeclared allergen; soy.

Class IHigh

FDAMar 17, 2023AZ, CA, HI +3 more• Mutual Trading Company Inc.

Fredericksburg Candles – Laceration Risk (2023)

Laceration Risk

This recall involves 10-ounce Scented Candles in a square glass jar with a glass lid. The model number and UPC code are printed on the label on the bottom of the jar. Fredericksburg Farms is printed on the front of the jar The following 15 scents of candles are included in the recall: The bag containing potassium hydroxide has a blue label with "POTASSIUM HYDROXIDE FLAKES." Model # Scent UPC Code D2001A West Texas Saddle Leather, 10 oz. 8 00565 80822 2 D2009A Buttery Vanilla, 10 oz. 8 00565 80826 0 D2011A Creme Brulee, 10 oz. (Small) 8 00565 80828 4 D2012A Spiced Orange, 10 oz. (Small) 8 00565 80830 7 D2013A Hill Country Christmas, 10 oz. (Small) 8 00565 80832 1 D2017A Bird of Paradise, 10 oz. (Small) 8 00565 80834 5 D2025A Hill Country Lavender, 10 oz. (Small) 8 00565 80840 6 D2042A Sandalwood Currant, 10 oz. (Small) 8 00565 80854 3 D3100A Texas Ruby Red Grapefruit, 10 oz. (Small) 8 00565 80856 7 D3101A Autumn Harvest, 10 o. 8 00565 80858 1 D3111A Spiced Chestnut, 10 oz. (Small) 8 00565 80876 5 D3112A Snowy Mountain Lodge, 10 oz. (Small) 8 00565 80877 2 D3113A Peppercorn & Ginger, 10 oz. (Small) 8 00565 80878 9 D3115A Teakwood & Mahogany, 10 oz. (Small) 8 00565 80880 2 D3116A Vanilla Birch, 10 oz. (Small) 8 00565 80881 9

High

CPSCMar 16, 2023Nationwide• Fredericksburg Distribution, dba Fredericksburg Farms, of Fredericksburg, Texas

JULIET Lumbar Plate (SpineArt) – potential disassembly (2023)

JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.

Moderate

FDAMar 16, 2023Nationwide• SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland

Polaris Sportsman ATV (Polaris) – Fire and Crash Hazards (2023)

Fire/Burn Risk

This recall involves certain VINs of model years 2021-2023 Sportsman 450 and 570 ATVs. The recalled ATVs were sold in the following colors: green, blue, beige, red, camouflage, gray, titanium metallic, black, white, azure crystal and orange. POLARIS is stamped on the front grille and POLARIS and Sportsman are printed on the sides of the vehicles. The model name is also printed on the side of the chassis. The VIN is located on the ATV's left rear frame. Consumers can enter their VIN online at www.polaris.com/en-us/off-road-recalls to check if their ATVs are recalled.

High

CPSCMar 16, 2023Nationwide• Polaris Industries Inc., of Medina, Minnesota

Simply Nature Organic Strawberries (Scenic Fruit) – Hepatitis A Risk (2023)

Potential to be contaminated with hepatitis A.

Class IHigh

FDAMar 16, 2023Nationwide• Scenic Fruit Company, LLC

Kirkland Signature Organic Strawberries (Scenic Fruit) – Hepatitis A Risk (2023)

Potential to be contaminated with hepatitis A.

Class IHigh

FDAMar 16, 2023Nationwide• Scenic Fruit Company, LLC

Trader Joe's Organic Tropical Fruit Blend (Scenic Fruit) – Hepatitis A Risk (2023)

Potential to be contaminated with hepatitis A.

Class IHigh

FDAMar 16, 2023Nationwide• Scenic Fruit Company, LLC

Almost Famous Popcorn Poppy Chow (Rieckhoff) - Undeclared Peanuts (2023)

Peanuts are declared in the ingredients statement, but they are not declared in the allergen contains statement.

Class IIModerate

FDAMar 13, 2023CO, IL, IN +11 more• Rieckhoff Family Businesses, Inc.

Quantum Perfusion Systems (Spectrum Medical) – bobbin lock fault (2023)

The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.

Moderate

FDAMar 13, 2023Nationwide• Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom

Aprepitant Capsules and Lidocaine Cream (Sandoz) - Drug Failure (2023)

This recall involves prescription drugs Aprepitant 125 mg capsules sold in cartons containing one blister card of 6 capsules and 5 gram tubes of Lidocaine and Prilocaine cream sold in cartons containing 5 tubes and packed with or without 12 dressings. The Aprepitant capsules are in a non-child resistant blister card packaged in a carton that has the name "Sandoz," the name of the medication, dosage, NDC number, lot number, and expiration date on the carton and on the blister cards. The warnings "This unit-dose packaging is not child-resistant" and "For institutional use only" are listed on the carton. The Lidocaine and Prilocaine cream is packaged in a 5 gram tube with a continuous thread white closure. The name "fougera®," the name of the medication, dosage and NDC number are printed on the carton and tube and the expiration date and lot number are printed on the carton and stamped on the crimp of the tube. The warning "FOR HOSPITAL USE ONLY" is printed on the carton and the tube. Product Description NDC Number Lot Number Expiration Date Aprepitant Capsules 125 mg 0781-2323-68 Carton of 1 Blister Pack of 6 capsules 0781-2323-06 Blister Pack LK3209 LC6454 04/2024 12/2023 Lidocaine and Prilocaine 2.5%/2.5% Cream 5 gram Tubes 0168-0357-56 Carton of 5 tubes and 12 dressings 0168-0357-55 Carton of 5 tubes 0168-0357-05 Tube LA2782 LA2784 LV0667 LX5350 MA1640 MB3205 LA2785 LR9041 MB3209 03/2023 03/2023 02/2024 03/2024 03/2024 04/2024 03/2023 11/2023 04/2024

Low

CPSCMar 9, 2023Nationwide• Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream)

AQURE Software (Radiometer) – Patient Mix-up Risk (2023)

Due to potential software issue that may result in patient mix-up information.

High

FDAMar 8, 2023Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Multi-Purpose Kids Bike Helmets (Huizhou Lanova) - head injury risk (2023)

This recall involves Ouwoer Kids Bike Helmets with production date 202201. The helmets are red with black straps and a black buckle. The production date is printed on a white label on the inside of the helmet.

High

CPSCMar 2, 2023Nationwide• Huizhou Lanova Outdoor Product Company, of China

Cirq Arm System 2.0 (Brainlab) – Mechanical Instability (2023)

Risk of mechanical instability due to potential manufacturing error of the device

High

FDAMar 2, 2023TX• Brainlab AG Olof-palme-str. 9 Munich Germany

CAPIOX RX15 Oxygenator (Terumo) – Thermistor Bonding (2023)

Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

High

FDAMar 1, 2023Nationwide• Terumo Cardiovascular Systems Corporation

CAPIOX NX19 Oxygenator (Terumo) – Thermistor Bonding (2023)

High

FDAMar 1, 2023Nationwide• Terumo Cardiovascular Systems Corporation

Leksell Stereotactic System Manuals (Elekta) – Incorrect IFU (2023)

The incorrect IFU was distributed with the devices.

Low

FDAMar 1, 2023Nationwide• Elekta Instrument AB Kungstensgatan 18 Stockholm Sweden