Class IIOngoingZ-1124-2026
Merit Medical Systems, Inc. recalls Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Recalls in Utah
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 66 recalls
Class IIOngoingZ-1123-2026
Merit Medical Systems, Inc. recalls Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN…
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-0602-2026
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Under Investigation by firm
BioFire Diagnostics, L…UTDec 3, 2025
Class IIOngoingZ-0533-2026
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Merit Medical Systems,…UTNov 26, 2025
Class IIOngoingZ-0432-2026
Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Total Joint Orthopedic…UTNov 12, 2025
Class IIOngoingZ-2609-2025
Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Biofire DefenseUTOct 1, 2025
Class IIOngoingZ-2553-2025
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTE…
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Merit Medical Systems,…UTSep 17, 2025
Class IIOngoingZ-2296-2025
Merit Medical Systems, Inc. recalls Custom Waste Management Kit: REF: K10-00353K
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2295-2025
Merit Medical Systems, Inc. recalls Custom Manifold Kit: REF: K09-02239C
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2294-2025
Merit Medical Systems, Inc. recalls Custom Tubing Kit: REF: K04-00417
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2293-2025
Merit Medical Systems, Inc. recalls High Pressure Tubing: REF: 502211002
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line.…
Merit Medical Systems,…UTAug 20, 2025
Class IIOngoingZ-2007-2025
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381434 BD Insyte Autoguard Shielded IV Catheter
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Becton Dickinson Infus…UTJul 2, 2025