Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Merit Medical Systems, Inc.

Merit Medical Systems, Inc. Recalls

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

Get alerts for this brand

Recall Summary

Total Recalls

309

Past Year

Class I (Serious)

Most Recent

Oct 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 21–40 of 309 recalls

Blue Diamond 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.

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

basixTOUCH 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.

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

IntelliSystem 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.

123 4...16

Page 2 of 16Next

FDA

Aug 19, 2024

Nationwide

• Merit Medical Systems, Inc.

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.

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

StabiliT TOUCH Syringe (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.

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

BlueFIRE 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.

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

Custom Inflation Kit (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.

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

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

7F sheath introducers labeled as 7.5F

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

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

7F sheath introducers labeled as 7.5F

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

Inspire Model 4340 Respiratory Sensing Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Inspire Model 4063 Stimulation Lead (Inspire) – Labeling Error (2024)

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

FDAJul 31, 2024Nationwide• Inspire Medical Systems Inc.

Merit Medical Convenience Kits (Merit Medical) - Syringe Issues (2024)

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

FDAJun 11, 2024Nationwide• Merit Medical Systems, Inc.

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

FDAMay 22, 2024Nationwide• Merit Medical Systems, Inc.

Inspire Model 3028 Pulse Generator (Inspire Medical) – Electrical Leakage (2024)

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

FDAMay 16, 2024Nationwide• Inspire Medical Systems Inc.

Infinity Acute Care System (Draeger) – Electrical Compliance Issue (2024)

Fire/Burn Risk

Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.

FDAMay 13, 2024Nationwide• Draeger Medical Systems, Inc.

Prelude Guide Sheath Roadster (Merit Medical) – Incorrect Dilator Risk (2024)

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

FDAMar 14, 2024Nationwide• Merit Medical Systems, Inc.

Tow-Behind Field Mowers (DR Power) – fire hazard (2023)

Fire/Burn Risk

This recall involves DR Power Equipment and Generac brand tow-behind field and brush mowers. The following model and serial numbers, printed on a white label that is on the rear frame of the mower near the right rear tire, are included in this recall. Name Model Number Serial Number Range DR Power Tow-Behind Field and Brush Mower TB 25044B EN All serial numbers beginning with TB2, plus 3002188267 to 30024310751 TB 25044B ENC 30030052232 to 3004525033 TB 25044B ENR 3004734233, 3004835965, 3005064288, 3005471720, 3005548665, 3007678624, 3008122643 TBM 20A ED TDVE OF1 All serial numbers beginning with TB; in addition, 300275210 TBM 20A EN TDVE OD3 All TBM 20A EN TDVE OF3 TBM20AENTDVEOF3 All 3002188263 to 3002490281 Generac Tow-Behind Field and Brush Mower TB 25044GENG 3003540054 to 3004428691

CPSCNov 9, 2023Nationwide• DR Power Equipment, of South Burlington, Vermont, a subsidiary of Generac Power Systems Inc., of Waukesha, Wisconsin (through January 2018)

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

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

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

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

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

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

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

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

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