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Natural Dentist Mouthwash (Revive) – Labeling Error (2021)

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

Class IIModerate

FDASep 28, 2021Nationwide• Revive Personal Products Company

Cardioblate CryoFlex Console (Medtronic) – Electrical Connectivity (2021)

There is potential for intermittent electrical connectivity between the console and probe.

FDASep 27, 2021IL, IN, KS +1 more• Medtronic Perfusion Systems

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Natural Dentist Mouthwash (Revive) – Labeling Error (2021)

Cardioblate CryoFlex Console (Medtronic) – Electrical Connectivity (2021)

Halyard Sterling Gloves (Halyard) – Material Degradation (2021)

Permobil TiLite Wheelchair (TiSport) – Transit Tie-Down Issue (2021)

Philips Azurion System (Philips) – 3D-RA Software Problem (2021)

Artis Zeego X-Ray (Siemens) – Table Rotation Software Error (2021)

Clinician Programmer (Medtronic) – Software Anomaly (2021)

Simplexa COVID-19 Control (DiaSorin) – Amplification Signal Delay (2021)

ImplantDirect Legacy 2 Implant (Implant Direct) – Size Mislabeling (2021)

ImplantDirect Legacy 2 Implant (Implant Direct) – Size Mislabeling (2021)

VIDAS Dimer Exclusion Test (bioMerieux) – Substrate Error (2021)

RayStation/RayPlan (RaySearch) – Density Grid Calculation Issue (2021)

VIDAS PRG Progesterone Test (bioMerieux) – Substrate Error (2021)

VIDAS RUB IgG Test (bioMerieux) – Substrate Error (2021)

VIDAS LH Test (bioMerieux) – Substrate Error (2021)

VIDAS Mumps IgG Test (bioMerieux) – Substrate Error (2021)

VIDAS Clostridium Difficile Test (bioMerieux) – Substrate Error (2021)

VIDAS Procalcitonin Test (bioMerieux) – Substrate Error (2021)

ProxiDiagnost N90 (Philips) – Label Compliance Issue (2021)

VIDAS SARS-CoV-2 IgM Test (bioMerieux) – Substrate Error (2021)