Safety Recalls

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15,186 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 3,401–3,450 of 15,186

Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Drug Test Small (4 substances)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Alcohol (ALC) Test Saliva
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
Pet Allergy Test
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
Orthofix U.S. LLC
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x
Labeling contains claims that are not consistently present.
Class III
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Urinary Tract Infection 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
PSA Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Hair Mineral Analysis
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
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Female Fertility 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
Akkermansia Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome 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
GET TESTED INTERNATIONAL AB
Food Intolerance Test Medium
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Men s Hormone Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Mycotoxin Panel 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
GET TESTED INTERNATIONAL AB
8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Fructose Intolerance Test
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
Gut Microbiome Test Medium
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
GET TESTED INTERNATIONAL AB
SIBO 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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Trichomonas Vaginalis 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
Peptic Ulcer Test (H, pylori)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Liver Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Iron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Vaginal PH Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Neurotransmitters Basic
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Gut Microbiome Test Large
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
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
GET TESTED INTERNATIONAL AB
Thyroid TSH Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
Vitamin D-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
Herpes (HSV-1 & HSV-2) Test
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
Neurotransmitters XL
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
IBS Test
Distribution without premarket approval/clearance.
Class II
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
GET TESTED INTERNATIONAL AB
Iron Deficiency Test
Distribution without premarket approval/clearance.
Class II
Medical Device Recall · November 3, 2025
GET TESTED INTERNATIONAL AB
D-Dimer 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