These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

3,615 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
Health & Personal Care
HIGH
FDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Due to Maintenance Risks

Datascope recalled 11,470 Intra-Aortic Balloon Pump systems on November 4, 2025. The recall addresses a revision in the Preventative Maintenance schedule as outlined in the Service Manual. Healthcare providers and patients must stop using these devices immediately.

Datascope
The IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Datascope Recalls Intra-Aortic Balloon Pump Over Maintenance Issues

Datascope recalled 47 units of its Cardiosave Rescue Intra-Aortic Balloon Pump on November 4, 2025. The recall addresses a revised Preventative Maintenance schedule in the device's instructions for use. This issue poses a high risk to patient safety and requires immediate attention from healthcare providers.

Datascope
The IFU
Read more
Food & Beverages
HIGH
FDA FOOD

Mangalm Recalls Tops Mixed Fruit Jam Due to Unapproved Color

Mangalm LLC recalled Tops Mixed Fruit Jam on November 4, 2025, due to the presence of an unapproved color, carmoisine. Consumers should not consume the product and should seek a refund or replacement. The affected jam has a UPC of 8 904288 626025 and a best before date of June 10, 2026.

Mangalm
Unapproved color
Read more
Food & Beverages
HIGH
FDA FOOD

Tops Strawberry Jam Recalled Over Unapproved Color Additive

Tops Strawberry Jam was recalled on November 4, 2025, due to the presence of an unapproved color additive, carmoisine. Consumers should not consume the product, which was distributed in California. The jam, manufactured by G.D. Foods Mfg. in India, has a best-before date of June 10, 2026.

Mangalm
Unapproved color
Read more
Food & Beverages
HIGH
FDA FOOD

Tai Phat Wholesalers Recalls Seedless Red Dates Over Sulfite Risk

Tai Phat Wholesalers recalled seedless red dates on November 4, 2025, due to undeclared sulfites. The recall affects 10 cases containing 50 packages of 12 oz each. Consumers should not consume the product and seek refunds.

Tai Phat Wholesalers
Undeclared sulfites
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Drug Test Small (4 Substances) Recall 2025

GET TESTED INTERNATIONAL AB distributed 1 unit nationwide in the United States. The device lacked premarket approval or clearance. Stop using the product immediately and contact GET TESTED INTERNATIONAL AB for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Syphilis Test Recalled in 2025 for PMA Lapse Nationwide

GET TESTED INTERNATIONAL AB recalled 528 syphilis tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using them immediately and follow the manufacturer's recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Hair Mineral Analysis Recall 19 Units (2025)

GET TESTED INTERNATIONAL AB recalled 19 Hair Mineral Analysis devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Sperm Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 33 units of its sperm test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Candida Test for Lack of Approval

GET TESTED INTERNATIONAL AB recalled 109 units of its Candida Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Allergy Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 76 units of its Allergy Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls Parasite Test Over Approval Issues

GET TESTED INTERNATIONAL AB recalled 94 units of its Parasite Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients should stop using the device immediately and follow provided instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB 8 in 1 STI Test Kit Recalled for 2,043 Units in 2025

GET TESTED INTERNATIONAL AB recalled 2,043 units of an 8 in 1 STI Test Kit sold nationwide in the United States. The recall is for distribution without premarket FDA approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions or contact the company for guidance.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Ferritin Iron Deficiency Test Recalled for Premarket Approval Issue (202

GET TESTED INTERNATIONAL AB recalled 115 ferritin iron deficiency tests distributed nationwide in the United States. The tests were distributed without FDA premarket approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Cholesterol Test Recall 2025 for 80 Units Nationwide

GET TESTED INTERNATIONAL AB recalled 80 Cholesterol Test devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Blood Type Test Recalled for Lack of Premarket Approval (47 Units) 2025

GET TESTED INTERNATIONAL AB recalled 47 Blood Type Test units distributed nationwide in the United States after discovering the device was distributed without FDA premarket approval or clearance. The hazard is distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 754 Units of 2 in 1 Trichomonas / Gardnerella Test (2025)

GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

Get Tested International AB Leaky Gut Test Recalled for Lack of FDA Approval (31 Units)

GET TESTED INTERNATIONAL AB recalled 31 Leaky Gut Test devices distributed nationwide in the United States after the product was found to be distributed without FDA premarket approval. The devices test for gut health but lack FDA clearance. Consumers should stop using the device immediately and contact the manufacturer for instructions.

Get Tested International AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Vitamin D2 and D3 Test Recall 10 Units Sold Nationwide (2025)

GET TESTED INTERNATIONAL AB recalled 10 Vitamin D2 and D3 Test kits distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB NAD Profile Test Recall 36 Units for Premarket Approval Issue (2025)

GET TESTED INTERNATIONAL AB recalled 36 NAD Profile Tests distributed nationwide in the United States after regulators found distribution without premarket approval. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions; contact GET TESTED INTERNATIONAL AB or your health‑ca

GET TESTED INTERNATIONAL AB
Distribution without
Read more
Advertisement