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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

309

Past Year

15

Class I (Serious)

3

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 141–160 of 309 recalls

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Prelude Short Sheath Introduc...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical GmbH, Unomedical Ltd., Catheter Fixation De...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical systems, Inc, Convenience Kit REF/CAT no.:...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

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Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Prelude Pro Sheath Introducer...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: ...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Advance Angiographic Needle label reading in part: ...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Futura Safety Scalpels, Futur...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog ...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Monarch Inflation Syringe CAT...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: Merit Medical Systems, Inc. Connection Tube label reading...

Potential sterility breach caused by excessive shipment damage.

FDASep 29, 2009AL, GA, KY +4 more• Merit Medical Systems, Inc.

Toshiba American Medical Systems Inc: SSH-880CV Aplio Artida System

Toshiba America Medical Systems (TAMS) is initiating a field correction on the SSH-880CV Aplio Artida System due to a problem related to a wrong measurement value display in using with DICOM viewer. When an image is transferred from this system in DICOM transfer and a measurement is performed on a Doppler image in the DICOM viewer, measured values such as VTI (Velocity Time Integral) and PI/RI

FDASep 16, 2009Nationwide• Toshiba American Medical Systems Inc

Draeger Medical Systems, Inc.: Heater Elements for Resuscitaire Infant Radiant Warmers m...

Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.

FDAJul 29, 2009Nationwide• Draeger Medical Systems, Inc.

Draeger Medical Systems, Inc.: Stabilet Infant Warming System, model numbers 200, 300, 1...

Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.

FDAJul 17, 2009Nationwide• Draeger Medical Systems, Inc.

Toshiba American Medical Systems Inc: Whole Body X--ray Scanner This device is indicated as ...

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

Class IIModerate

FDAJul 13, 2009Nationwide• Toshiba American Medical Systems Inc

Toshiba American Medical Systems Inc: Whole Body X--ray Scanner This device is indicated as a ...

1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco

FDAJul 13, 2009Nationwide• Toshiba American Medical Systems Inc

Computerized Medical Systems Inc: Focal Radiation Treatment Planning System, Focal Release...

Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.

FDAJun 12, 2009Nationwide• Computerized Medical Systems Inc

Toshiba American Medical Systems Inc: Toshiba America Medical Systems Inc (TAMS) Digital Radiog...

Toshiba America Medical Systems Inc (TAMS) has initiated a field correction on the DRAD-3000E; Radrex-I, Electrostatic x-ray imaging system due to a software bug that results in a loss of image.

FDAMay 22, 2009Nationwide• Toshiba American Medical Systems Inc

Merit Medical Systems, Inc.: Merit Medical Systems, Inc., Convenience Trays, custom pa...

Surgical gloves in hospital convenience kits may be degraded and tear during use.

FDAMay 19, 2009CO, IN, TX• Merit Medical Systems, Inc.

Computerized Medical Systems Inc: XiO Radiation Treatment Planning System, XiO Release 4.3....

In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only.

FDAMay 13, 2009Nationwide• Computerized Medical Systems Inc

Toshiba American Medical Systems Inc: PET-511BTM Multi-plane transesophageal transducer (TEE) u...

Toshiba America Medical Systems Inc is removing the PET-511BTM Multi-plane Transesophageal Transducer from the market after receiving several reports of injury regarding the transducer. Bending or buckling of the flexible portion of the PET-511 BTM multi-plane transesophageal transducer (TEE) may result in injury including perforation.

FDAMay 11, 2009Nationwide• Toshiba American Medical Systems Inc