All recalls8,504 total

Nov 3

G

GET TESTED INTERNATIONAL AB — NAD Profile Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Vitamin D2 and D3 Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Leaky Gut Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Kidney Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — 2 in 1 Trichomonas / Gardnerella Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Menopause (FSH) 2 Tests

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Blood Type Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — 3 in 1 STI Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Biological Age & Longevity Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Lyme Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Drug Test Small (4 substances)

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Organic acids Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Hair Mineral Analysis

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Gut Microbiome Test Large

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Chlamydia Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Gonorrhea test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Cholesterol Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Iron Deficiency Test (ferritin)

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Thyroid TSH Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Herpes (HSV-1 & HSV-2) Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Iron Deficiency Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Diabetes Test (ketones & glucose)

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Liver Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Pregnancy Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Allergy & Food Intolerance Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Ovulation Test (5 tests)

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Food Sensitivity Test Medium

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Men s Hormone Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — H pylori (Peptic ulcer) Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Neurotransmitters Basic

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Fecal Occult Blood Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Women s Hormone Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Melatonin Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

O

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

Labeling contains claims that are not consistently present.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Neurotransmitters XL

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — IBS Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Sorbitol Intolerance Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

O

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 Spa

Labeling contains claims that are not consistently present.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Environmental Pollutants Profile Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Vaginal PH Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Gut Microbiome Test Medium

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

O

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 14

Labeling contains claims that are not consistently present.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Estrogen & Progesterone Test

Distribution without premarket approval/clearance.

FDAHealth

Nov 3

G

GET TESTED INTERNATIONAL AB — Continuous Glucose Monitor (CGM)

Distribution without premarket approval/clearance.

FDAHealth

Nov 2

M

Medtronic MiniMed, Inc. — MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years wi

A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

FDAHealth

Oct 31

H

HANA GROUP — Mai California Roll WR - UPC 840031402639 5.9 oz (167g) Plastic tray with plastic lid

Wheat and Soy missing allergens from the product Contains Statement.

FDAFood

Oct 31

B

Blonde Beard's — Blonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce condiment, shelf stable, 2 years, glass bottle, 8 oz, Blonde Beard s. Responsible firm on label: Blonde Beard s 2230 S Brau

Undeclared Soy

FDAFood

Oct 31

B

BULK & ORGANIC LLC — Bulk and Organic Organic Moringa Powder, 44.1lbs bag

Possible Salmonella Richmond

FDAFood

Oct 31

F

First & Last Tavern — First & Last Tavern Marinara Sauce (tomato & basil) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

FDAFood

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