Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 2,401–2,450 of 8,689

Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Melatonin Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
NAD Profile Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Men s Hormone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Environmental Pollutants Profile Test
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
GET TESTED INTERNATIONAL AB
Food Intolerance Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Mycoplasma test, IgG and IgM
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Sperm Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Hair Mineral Analysis
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Fecal Occult Blood Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Women s Hormone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gonorrhea test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Gut Microbiome Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Gut Microbiome Test XL
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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IBS Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Syphilis Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
MPOX 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
GET TESTED INTERNATIONAL AB
Allergy test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
HPV Antigen Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Par
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Intolerance Test Large
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
GET TESTED INTERNATIONAL AB
Kidney Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
Fresenius Kabi USA, LLC
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class I
Medical Device Recall · November 3, 2025
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Allergy test Small
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Continuous Glucose Monitor (CGM)
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
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
GET TESTED INTERNATIONAL AB
Diabetes Test (ketones & glucose)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Allergy Test IgE
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Food Sensitivity Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Estrogen & Progesterone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Organic Acids Profile Test Large
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Peptic Ulcer Test (H, pylori)
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
H pylori (Peptic ulcer) Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Sorbitol Intolerance Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Vitamin D2 and D3 Test
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
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
GET TESTED INTERNATIONAL AB
SIBO 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
Serotonin Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Female Fertility 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
Food Allergy Panel Test (IgE)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Akkermansia Test
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