December 2025 recalls

744 recalls were announced in December 2025.

What the numbers show

Critical: 102
Severe: 54
High: 363
Moderate: 217
Low: 8

Of the 744 recalls this month scored against our rubric, 14% are Critical, 7% are Severe.

Which agencies issued them

401–500 of 744

HighFDA (Food)·H-0233-2026·2025-12-10
Prenatal chewable vitamins recalled over undeclared soy and a boron labeling error
Avion Pharmaceuticals is recalling 804 bottles of Prenate Chewable after positive test results for soy, which is not listed on the label, and a boron amount stated in mg instead of mcg.
Product
Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005
Category
Drug
Distribution
17 states
HighFDA (Food)·H-0227-2026·2025-12-10
Chocolate ice cream bars recalled over undeclared wheat in one lot
Dreyer's Grand Ice Cream is recalling 3,410 cases of Haagen-Dazs mini chocolate dark chocolate ice cream bars over undeclared wheat.
Product
Retail Box: Haagen-Dazs mini chocolate dark chocolate ice cream bars 6 BARS/11.1 FL/OZ(328mL) INGREDIENTS: CHOCOLATE ICE CREAM: CREAM, SKIM MILK, SUGAR, COCOA PROCESSED WITH ALKALI, EGG YOLKS. DARK CHOCOLATE AND VEGETABLE OIL COATING: DARK CHOCOLATE (SUGAR, CHOCOLATE, SOY LECITHI
Category
Food
Distribution
4 states
HighFDA (Food)·H-0219-2026·2025-12-10
Pizza style shredded cheese recalled over potential metal fragments from a supplier
Great Lakes Cheese is recalling 4,298 cases of pizza style shredded cheese blend, sold under six brands, over potential metal fragments originating in a supplier raw material.
Product
Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar cheeses), individually packaged in a plastic bag as: 1) Econo Pizza - Shredded, 8 oz., UPC 893800297, 12/case 2) Food Club Pizza Style Two Cheese Blend - Finely Shredded, 8 oz., UPC
Category
Food
Distribution
32 states
HighFDA (Food)·H-0230-2026·2025-12-10
Frozen lava buns recalled because milk is not declared on the label
Prime Food Processing is recalling 2,243 cases of frozen Lava Bun with Salted Egg Yolk because the products do not declare milk in the Contains statement or the ingredient statement.
Product
Lava Bun with Salted Egg Yolk orange packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Category
Food
Distribution
33 states
HighFDA (Food)·H-0232-2026·2025-12-10
Irradiated onion granules recalled over black plastic planting film found inside
Laiwu Manhing Vegetables Fruits is recalling 245 cartons of irradiated onion granules after foreign objects, described as black plastic planting film, were found in the granulated onion powder.
Product
Onion granules (irradiated) ; 55 lbs carton Item# 5358
Category
Food
Distribution
1 state
HighFDA (Food)·H-0229-2026·2025-12-10
Green tea lava buns recalled because milk is not declared
Prime Food Processing is recalling frozen Lava Bun with Green Tea Flavor because the products do not declare milk in the Contains statement or the ingredient statement.
Product
Lava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Category
Food
Distribution
33 states
HighFDA (Food)·H-0217-2026·2025-12-10
Italian style shredded cheese recalled over potential metal fragments from a supplier
Great Lakes Cheese is recalling 15,490 cases of Italian style shredded cheese blend, sold under eight brands, over potential metal fragments originating in a supplier raw material.
Product
Italian style shredded cheese blend (containing low-moisture part-skim mozzarella, provolone, parmesan, romano, fontina and asiago cheese), individually packaged in a plastic bag, as: 1) Brookshire's Italian 6-Cheese - Finely Shredded, 8 oz., UPC 9282510174, 12/case 2) Cache Va
Category
Food
Distribution
32 states
HighFDA (Drugs)·D-0216-2026·2025-12-10
Duloxetine delayed-release capsules recalled over a nitrosamine impurity above FDA limits
Breckenridge Pharmaceutical is recalling 7,389 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2026·2025-12-10
IntelliVue MX850 patient monitors recalled over the potential failure to alarm
Philips North America is recalling the IntelliVue Patient Monitor MX850 over a potential issue where the monitors did not alarm.
Product
IntelliVue Patient Monitor MX850. Product Number: 866470.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0750-2026·2025-12-10
Sperm tests, SKU A-SPE, recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 33 units of its Sperm Test because the product was distributed without premarket approval or clearance.
Product
Sperm Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0205-2026·2025-12-10
WeCare zinc oxide ointment recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 2,592 bottles of WeCare Zinc Oxide Ointment, 15 oz, over current good manufacturing practice deviations.
Product
ZINC OXIDE — ZINC OXIDE (ZINC OXIDE OINTMENT)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0200-2026·2025-12-10
Compounded phenylephrine syringes recalled over current good manufacturing practice deviations
Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCl, 1000 mcg / 10 mL, over current good manufacturing practice deviations.
Product
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-0726-2026·2025-12-10
Kidney tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 100 units of its Kidney Test because the product was distributed without premarket approval or clearance.
Product
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0209-2026·2025-12-10
Nivagen zinc oxide ointment, 1 ounce bottles, recalled over manufacturing deviations
Blossom Pharmaceuticals is recalling 7,920 bottles of Nivagen Zinc Oxide Ointment USP 20%, 1 oz, over current good manufacturing practice deviations.
Product
NIVAGEN ZINC OXIDE — NIVAGEN ZINC OXIDE (ZINC OXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0211-2026·2025-12-10
Clotrimazole cream, 5 ounce size, recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 14700 bottles of Globe Clotrimazole Cream USP over current good manufacturing practice deviations.
Product
CLOTRIMAZOLE — CLOTRIMAZOLE (CLOTRIMAZOLE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0808-2026·2025-12-10
Food Intolerance Test Small recalled for distribution without premarket clearance
Get Tested International AB is recalling 5 units of its Food Intolerance Test Small because the product was distributed without premarket approval or clearance.
Product
Food Intolerance Test Small
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0775-2026·2025-12-10
Candida test kits, SKU 2A120, recalled for lacking premarket clearance
Get Tested International AB is recalling 109 units of its Candida Test because the product was distributed without premarket approval or clearance.
Product
Candida Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0769-2026·2025-12-10
Allergy IgE tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 71 units of its Allergy Test IgE because the product was distributed without premarket approval or clearance.
Product
Allergy Test IgE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0761-2026·2025-12-10
Food Sensitivity Test Medium recalled for distribution without premarket clearance
Get Tested International AB is recalling 1 unit of its Food Sensitivity Test Medium because the product was distributed without premarket approval or clearance.
Product
Food Sensitivity Test Medium
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0764-2026·2025-12-10
GI Microbiome Profile XL recalled for distribution without premarket clearance
Get Tested International AB is recalling 3 units of its GI Microbiome Profile XL because the product was distributed without premarket approval or clearance.
Product
GI Microbiome Profile XL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0204-2026·2025-12-10
Wound hydrogel recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 8,184 bottles of Dynagel Moisturizing Wound Hydrogel over current good manufacturing practice deviations.
Product
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0883-2026·2025-12-10
Parasite tests, SKU 2A178, recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 94 units of its Parasite Test because the product was distributed without premarket approval or clearance.
Product
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0778-2026·2025-12-10
Gut Microbiome Test Large recalled for distribution without premarket clearance
Get Tested International AB is recalling 3 units of its Gut Microbiome Test Large because the product was distributed without premarket approval or clearance.
Product
Gut Microbiome Test Large
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0767-2026·2025-12-10
Organic Acids Profile Test Large recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 1 unit of its Organic Acids Profile Test Large because the product was distributed without premarket approval or clearance.
Product
Organic Acids Profile Test Large
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0790-2026·2025-12-10
Neurotransmitters Basic test recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 18 units of its Neurotransmitters Basic because the product was distributed without premarket approval or clearance.
Product
Neurotransmitters Plus
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0848-2026·2025-12-10
Infusion pumps recalled over downstream occlusion alarms at low flow rates
Fresenius Kabi USA is recalling 15,862 Ivenix Infusion System large volume pumps because downstream occlusion alarms may occur at low flow rates when a check valve is added to the administration set.
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2026·2025-12-10
Saliva alcohol tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 1 unit of its Alcohol (ALC) Test Saliva because the product was distributed without premarket approval or clearance.
Product
Alcohol (ALC) Test Saliva
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0795-2026·2025-12-10
PSA test kits recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 27 units of its PSA Test because the product was distributed without premarket approval or clearance.
Product
PSA Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0814-2026·2025-12-10
Pollen allergy tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 10 units of its Pollen Allergy Test because the product was distributed without premarket approval or clearance.
Product
Pollen Allergy Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0781-2026·2025-12-10
Gut microbiome tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 6 units of its Gut Microbiome Test Small because the product was distributed without premarket approval or clearance.
Product
Gut Microbiome Test Small
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0818-2026·2025-12-10
Eight-in-one STI test kits recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 2043 units of its 8 in 1 STI Test Kit because the product was distributed without premarket approval or clearance.
Product
8 in 1 STI Test Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0773-2026·2025-12-10
Akkermansia tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 24 units of its Akkermansia Test because the product was distributed without premarket approval or clearance.
Product
Akkermansia Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0878-2026·2025-12-10
MAMMOMAT Inspiration systems recalled because operator tables shipped with bus-installation kits
Siemens Medical Solutions USA is recalling 6 MAMMOMAT Inspiration systems because operator tables were sold together with a bus-installation kit they are not released for.
Product
MAMMOMAT Inspiration;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0807-2026·2025-12-10
Food Intolerance Test Medium recalled for distribution without premarket clearance
Get Tested International AB is recalling 16 units of its Food Intolerance Test Medium because the product was distributed without premarket approval or clearance.
Product
Food Intolerance Test Medium
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0879-2026·2025-12-10
MAMMOMAT Fusion system recalled because an operator table shipped with a bus-installation kit
Siemens Medical Solutions USA is recalling one MAMMOMAT Fusion system because an operator table was sold together with a bus-installation kit it is not released for.
Product
MAMMOMAT Fusion;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0796-2026·2025-12-10
SIBO tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 55 units of its SIBO Test because the product was distributed without premarket approval or clearance.
Product
SIBO Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0815-2026·2025-12-10
Serotonin tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 12 units of its Serotonin Test because the product was distributed without premarket approval or clearance.
Product
Serotonin Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0730-2026·2025-12-10
Chlamydia tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 5 units of its Chlamydia Test because the product was distributed without premarket approval or clearance.
Product
Chlamydia Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0877-2026·2025-12-10
MAMMOMAT Revelation systems recalled because operator tables shipped with bus-installation kits
Siemens Medical Solutions USA is recalling 7 MAMMOMAT Revelation systems because operator tables were sold together with a bus-installation kit they are not released for.
Product
MAMMOMAT Revelation;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0740-2026·2025-12-10
Liver tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling its Liver Test because the product was distributed without premarket approval or clearance.
Product
Herpes (HSV-1 & HSV-2) Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0802-2026·2025-12-10
Allergy and food intolerance tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 16 units of its Allergy & Food Intolerance Test because the product was distributed without premarket approval or clearance.
Product
Allergy & Food Intolerance Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0788-2026·2025-12-10
Gut Microbiome Test Medium recalled for distribution without premarket clearance
Get Tested International AB is recalling 3 units of its Gut Microbiome Test Medium because the product was distributed without premarket approval or clearance.
Product
Men s Hormone Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0779-2026·2025-12-10
Herpes HSV-1 and HSV-2 tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 1361 units of its Herpes (HSV-1 & HSV-2) Test because the product was distributed without premarket approval or clearance.
Product
Gut Microbiome Test Medium
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0799-2026·2025-12-10
Diabetes ketones and glucose tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 48 units of its Diabetes Test (ketones & glucose) because the product was distributed without premarket approval or clearance.
Product
Diabetes Test (ketones & glucose)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0863-2026·2025-12-10
HPV antigen tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 258 units of its HPV Antigen Test because the product was distributed without premarket approval or clearance.
Product
IntelliVue Patient Monitor MX450. Product Number: 866062.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0734-2026·2025-12-10
Drug Test Small, four substances, recalled for lacking premarket clearance
Get Tested International AB is recalling 1 unit of its Drug Test Small (4 substances) because the product was distributed without premarket approval or clearance.
Product
Drug Test Small (4 substances)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0755-2026·2025-12-10
Vaginal pH tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 31 units of its Vaginal PH Test because the product was distributed without premarket approval or clearance.
Product
Vaginal PH Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0749-2026·2025-12-10
Women's hormone tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 37 units of its Women's Hormone Test because the product was distributed without premarket approval or clearance.
Product
Pregnancy Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0811-2026·2025-12-10
Iron deficiency ferritin tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 115 units of its Iron Deficiency Test (ferritin) because the product was distributed without premarket approval or clearance.
Product
Iron Deficiency Test (ferritin)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0737-2026·2025-12-10
H. pylori peptic ulcer tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 239 units of its H pylori (Peptic ulcer) Test because the product was distributed without premarket approval or clearance.
Product
Female Fertility Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0780-2026·2025-12-10
Pregnancy tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 2 units of its Pregnancy Test because the product was distributed without premarket approval or clearance.
Product
Gut Microbiome Test Mega
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0771-2026·2025-12-10
Candida test kits, SKU B-CAN, recalled for lacking premarket clearance
Get Tested International AB is recalling 166 units of its Candida Test because the product was distributed without premarket approval or clearance.
Product
Cholesterol Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0199-2026·2025-12-10
Bisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
Glenmark Pharmaceuticals is recalling 11,136 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets after reserve sample testing showed traces of ezetimibe.
Product
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0759-2026·2025-12-10
Food allergy IgE panel tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 3 units of its Food Allergy Panel Test (IgE) because the product was distributed without premarket approval or clearance.
Product
Food Allergy Panel Test (IgE)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0214-2026·2025-12-10
Haloperidol injection vials recalled over incorrect RFID tag labels
Safecor Health is recalling 800 vials of Haloperidol Lactate Injection because incorrect RFID tag labels were applied to the product by the repackaging firm.
Product
HALOPERIDOL LACTATE — HALOPERIDOL LACTATE (HALOPERIDOL LACTATE)
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-0777-2026·2025-12-10
Fructose intolerance tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 8 units of its Fructose Intolerance Test because the product was distributed without premarket approval or clearance.
Product
Fructose Intolerance Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0742-2026·2025-12-10
Iron deficiency tests, SKU A-FER, recalled for lacking premarket clearance
Get Tested International AB is recalling 5187 units of its Iron Deficiency Test because the product was distributed without premarket approval or clearance.
Product
Iron Deficiency Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0748-2026·2025-12-10
Parasite tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 658 units of its Parasite Test because the product was distributed without premarket approval or clearance.
Product
Parasite Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0744-2026·2025-12-10
Menopause FSH test kits recalled for distribution without premarket clearance
Get Tested International AB is recalling 184 units of its Menopause (FSH) 2 Tests because the product was distributed without premarket approval or clearance.
Product
Menopause (FSH) 2 Tests
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0758-2026·2025-12-10
Environmental Pollutants Profile Test recalled for distribution without premarket clearance
Get Tested International AB is recalling 1 unit of its Environmental Pollutants Profile Test because the product was distributed without premarket approval or clearance.
Product
Environmental Pollutants Profile Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0849-2026·2025-12-10
Mycoplasma IgG and IgM tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 23 units of its Mycoplasma test, IgG and IgM because the product was distributed without premarket approval or clearance.
Product
IntelliVue MP2. Product Number: M8102A.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0746-2026·2025-12-10
Cholesterol tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 80 units of its Cholesterol Test because the product was distributed without premarket approval or clearance.
Product
Mycoplasma test, IgG and IgM
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0762-2026·2025-12-10
Food Sensitivity Test Small recalled for distribution without premarket clearance
Get Tested International AB is recalling 3 units of its Food Sensitivity Test Small because the product was distributed without premarket approval or clearance.
Product
Food Sensitivity Test Small
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0763-2026·2025-12-10
GI Microbiome Profile Small recalled for distribution without premarket clearance
Get Tested International AB is recalling 1 unit of its GI Microbiome Profile Small because the product was distributed without premarket approval or clearance.
Product
GI Microbiome Profile Small
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0736-2026·2025-12-10
Fecal occult blood tests recalled for distribution without premarket clearance
Get Tested International AB is recalling 35 units of its Fecal Occult Blood Test because the product was distributed without premarket approval or clearance.
Product
Fecal Occult Blood Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0783-2026·2025-12-10
Hair Mineral Analysis kits recalled for distribution without premarket clearance
Get Tested International AB is recalling 19 units of its Hair Mineral Analysis because the product was distributed without premarket approval or clearance.
Product
Hair Mineral Analysis
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0766-2026·2025-12-10
NAD Profile Test recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 36 units of its NAD Profile Test because the product was distributed without premarket approval or clearance.
Product
NAD Profile Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0743-2026·2025-12-10
Lyme tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 940 units of its Lyme Test because the product was distributed without premarket approval or clearance.
Product
Lyme Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0201-2026·2025-12-10
Lanashield Skin Barrier recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 9600 containers of Lanashield Skin Barrier over current good manufacturing practice deviations.
Product
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0208-2026·2025-12-10
Nivagen zinc oxide ointment recalled over good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 13536 containers of Nivagen Zinc Oxide Ointment over current good manufacturing practice deviations.
Product
NIVAGEN ZINC OXIDE — NIVAGEN ZINC OXIDE (ZINC OXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0787-2026·2025-12-10
Leaky gut tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 31 units of its Leaky Gut Test because the product was distributed without premarket approval or clearance.
Product
Leaky Gut Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0876-2026·2025-12-10
Culture media quality control kits recalled over mislabeled lot numbers on pouches
Microbiologics is recalling 5 KWIK-STIK quality control kits because some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Product
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0729-2026·2025-12-10
Ovulation test kits recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 128 units of its Ovulation Test (5 tests) because the product was distributed without premarket approval or clearance.
Product
Candida Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0784-2026·2025-12-10
IBS tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 8 units of its IBS Test because the product was distributed without premarket approval or clearance.
Product
IBS Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0760-2026·2025-12-10
Food Sensitivity Test Large recalled for distribution without premarket clearance
Get Tested International AB is recalling 3 units of its Food Sensitivity Test Large because the product was distributed without premarket approval or clearance.
Product
Food Sensitivity Test Large
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0860-2026·2025-12-10
Peptic ulcer H. pylori tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 12 units of its Peptic Ulcer Test (H. pylori) because the product was distributed without premarket approval or clearance.
Product
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0789-2026·2025-12-10
Men's hormone tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 10 units of its Men's Hormone Test because the product was distributed without premarket approval or clearance.
Product
Neurotransmitters Basic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0792-2026·2025-12-10
Organic acids tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 4 units of its Organic acids Test because the product was distributed without premarket approval or clearance.
Product
Organic acids Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0772-2026·2025-12-10
Adrenal tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 17 units of its Adrenal Test because the product was distributed without premarket approval or clearance.
Product
Adrenal Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0203-2026·2025-12-10
Gut Microbiome Test Mega recalled for distribution without premarket clearance
Get Tested International AB is recalling 2 units of its Gut Microbiome Test Mega because the product was distributed without premarket approval or clearance.
Product
SALINE ENEMA — SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0810-2026·2025-12-10
Iodine tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 13 units of its Iodine Test because the product was distributed without premarket approval or clearance.
Product
Iodine Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0728-2026·2025-12-10
Blood type tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 47 units of its Blood Type Test because the product was distributed without premarket approval or clearance.
Product
Blood Type Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0847-2026·2025-12-10
Blood pressure cuff bladder kits recalled for containing the wrong size bladder
Baxter Healthcare is recalling 118 Welch Allyn thigh replacement bladder kits because a kit may contain a Large Adult size bladder rather than a Thigh size bladder.
Product
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0733-2026·2025-12-10
Product SKU A-DR12 recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling a product identified only by EAN 7340221701083 and SKU A-DR12, because it was distributed without premarket approval or clearance.
Product
Illegally Marketed
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0812-2026·2025-12-10
Melatonin tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 12 units of its Melatonin Test because the product was distributed without premarket approval or clearance.
Product
Melatonin Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0798-2026·2025-12-10
Wecare Enema recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 18,912 containers of Wecare Enema, 4.5 Fl Oz, over current good manufacturing practice deviations.
Product
Women s Hormone Test
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0741-2026·2025-12-10
Vitamin D tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 1557 units of its Vitamin D-Test because the product was distributed without premarket approval or clearance.
Product
HPV Antigen Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0207-2026·2025-12-10
Dynashield cream recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 7,944 containers of Dynashield 4 oz cream over current good manufacturing practice deviations.
Product
DYNASHIELD — DYNASHIELD (ZINC OXIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0881-2026·2025-12-10
Incisive CT systems recalled because tube heat exchanger screws may not be tightened
Philips North America is recalling 2,341 Incisive CT systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.
Product
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0774-2026·2025-12-10
Biological age and longevity tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 3 units of its Biological Age & Longevity Test because the product was distributed without premarket approval or clearance.
Product
Biological Age & Longevity Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0732-2026·2025-12-10
Wecare Calasoothe recalled over current good manufacturing practice deviations
Blossom Pharmaceuticals is recalling 2400 containers of Wecare Calasoothe over current good manufacturing practice deviations.
Product
Diabetes HbA1c Test
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0791-2026·2025-12-10
Neurotransmitters XL test recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 14 units of its Neurotransmitters XL because the product was distributed without premarket approval or clearance.
Product
Neurotransmitters XL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0861-2026·2025-12-10
DHEA tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 17 units of its DHEA Test because the product was distributed without premarket approval or clearance.
Product
IntelliVue Patient Monitor MX100. Product Number: 867033.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0745-2026·2025-12-10
MPOX tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 4 units of its MPOX Test because the product was distributed without premarket approval or clearance.
Product
MPOX Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0731-2026·2025-12-10
D-Dimer tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 1218 units of its D-Dimer Test because the product was distributed without premarket approval or clearance.
Product
D-Dimer Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0797-2026·2025-12-10
Sorbitol intolerance tests recalled for distribution without premarket clearance or approval
Get Tested International AB is recalling its Sorbitol Intolerance Test because the product was distributed without premarket approval or clearance.
Product
Sorbitol Intolerance Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0817-2026·2025-12-10
Three-in-one STI tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 1210 units of its 3 in 1 STI Test because the product was distributed without premarket approval or clearance.
Product
3 in 1 STI Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0806-2026·2025-12-10
Food Intolerance Test Large recalled for distribution without premarket clearance
Get Tested International AB is recalling 6 units of its Food Intolerance Test Large because the product was distributed without premarket approval or clearance.
Product
Food Intolerance Test Large
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0768-2026·2025-12-10
Vitamin D2 and D3 tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 10 units of its Vitamin D2 and D3 Test because the product was distributed without premarket approval or clearance.
Product
Vitamin D2 and D3 Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0794-2026·2025-12-10
Neurotransmitters Plus test recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 18 units of its Neurotransmitters Plus because the product was distributed without premarket approval or clearance.
Product
Peptic Ulcer Test (H, pylori)
Category
Medical Device
Distribution
Distributed nationwide

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