Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 1,701–1,750 of 7,959

Medical Device Recall · November 3, 2025
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Trichomonas Vaginalis test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Liver Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Iron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Vaginal PH Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Gut Microbiome Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class II
Medical Device Recall · November 3, 2025
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Thyroid TSH Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Vitamin D-Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Herpes (HSV-1 & HSV-2) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Diabetes HbA1c Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Allergy Test IgE
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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MPOX Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
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;
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
GI Microbiome Profile Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Parasite Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
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¿, 9
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Iron Deficiency Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Lactose Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Allergy test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Parasite Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Adrenal Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Gut Microbiome Test Mega
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Continuous Glucose Monitor (CGM)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GVS TM, Inc
SQ40S Blood Transfusion Filter
Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.
Class II
Medical Device Recall · November 3, 2025
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Food Intolerance Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Pregnancy Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Allergy & Food Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Fecal Occult Blood Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Mycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Women s Hormone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Melatonin Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Neurotransmitters XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Ovulation Test (5 tests)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Sorbitol Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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GI Microbiome Profile XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Illegally Marketed
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Food Sensitivity Test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
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 11
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
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Organic Acids Profile Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Neurotransmitters Plus
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GE Healthcare GmbH
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Allergy test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Heavy Metals Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Intestinal Worms Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Candida Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
DHEA Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Serotonin Test
Distribution without premarket approval/clearance.
Class II