Calendar

pharmadog

Week of Nov 3, 2025

Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Blood Type Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

3 in 1 STI Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Biological Age & Longevity Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Lyme Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Drug Test Small (4 substances) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Organic acids Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Hair Mineral Analysis — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gut Microbiome Test Large — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Chlamydia Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gonorrhea test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Cholesterol Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Sri Devaraj Urs Academy of Higher Education and Research

Iron Deficiency Test (ferritin) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Thyroid TSH Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Herpes (HSV-1 & HSV-2) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Sri Devaraj Urs Academy of Higher Education and Research

Iron Deficiency Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Diabetes Test (ketones & glucose) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Liver Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Pregnancy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Allergy & Food Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Ovulation Test (5 tests) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Sensitivity Test Medium — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Men s Hormone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

H pylori (Peptic ulcer) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Neurotransmitters Basic — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Epstein-Barr Virus (EBV VCA & EBNA IgG) Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Fecal Occult Blood Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Women s Hormone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)Worphmed Srl

Melatonin Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Neurotransmitters XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

IBS Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Sorbitol Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Environmental Pollutants Profile Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Vaginal PH Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Gut Microbiome Test Medium — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG PTC IMPLANT; 39-9212SP 33W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-9214SP 33W X 28L X 14H, 12DEG PTC IMPLANT; 39-9216SP 33W X 28L X 16H, 12DEG PTC IMPLANT; 39-9218SP 33W X 28L X 18H, 12DEG PTC IMPLANT; 39-2012SP 37W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-2014SP 37W X 28L X 14H, 7DEG PTC IMPLANT; 39-2016SP 37W X 28L X 16H, 7DEG PTC IMPLANT; 39-2018SP 37W X 28L X 18H, 7DEG PTC IMPLANT; 39-2212SP 37W X 28L X 12.5H, 12DEG PTC IMPLANT; 39-2214SP 37W X 28L X 14H, 12DEG PTC IMPLANT; 39-2216SP 37W X 28L X 16H, 12DEG PTC IMPLANT; 39-2218SP 37W X 28L X 18H, 12DEG PTC IMPLANT; — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)IBSA Institut Biochimique SA

Estrogen & Progesterone Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Continuous Glucose Monitor (CGM) — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall266d agoOrthofix U.S. LLC device recall (Cls III)

Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer, — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing

Nov 3, 2025device recall266d agoGVS TM, Inc device recall (Cls II)

SQ40S Blood Transfusion Filter — Reason: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. — Status: Ongoing

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Nov 4, 2025device recall265d agoDatascope Corp. device recall (Cls II)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 4, 2025device recall265d agoDatascope Corp. device recall (Cls II)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. — Reason: The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. — Status: Ongoing

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Nov 5, 2025device recall264d agoCepheid device recall (Cls II)

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. — Reason: Product testing did not meet expected stability criteria. — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall264d agoAccriva Diagnostics, Inc. device recall (Cls II)Co-Diagnostics, Inc.

Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System — Reason: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Nov 5, 2025device recall264d agoDiasol, Inc device recall (Cls II)

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters — Reason: Safety and efficacy of dialysis acid concentrate cannot be assured — Status: Ongoing

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Week of Nov 3, 2025