immediate action Recalls

2,756 recalls tagged with “immediate action”.

Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 2,200 gallons of its 100425-10-DEX100 liquid concentrate for bicarbonate dialysis on November 5, 2025. The company cannot assure the safety and efficacy of the product. Patients and healthcare providers should stop using it immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 7,200 gallons of its 100125-10-DEX100 liquid concentrate on November 5, 2025. The recall affects dialysis patients in multiple states due to unassured safety and efficacy. Patients and healthcare providers must stop using this product immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Cepheid Xpert MTB/RIF GXMTB/RIF-US-10 Recall Affects 9,880 Units in 2025

Cepheid recalled 9,880 units of Xpert MTB/RIF GXMTB/RIF-US-10 after testing failed to meet stability criteria. The devices were distributed nationwide in the United States and Puerto Rico. Health care providers and patients should stop using the device immediately and follow the recall instructions.

Cepheid
Product testing
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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
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Vehicles & Parts
HIGH
NHTSA

Hyundai IONIQ 5 N Recalled for Brake and Acceleration Software Issues (2025)

Hyundai Motor America recalls 2025 Hyundai IONIQ 5 N vehicles with left-foot braking and N e-shift features. The recall cites potential reduced braking performance and continued acceleration after pedal release. Owners should avoid LFB and N e-shift until remedy is complete. OTA or dealer updates are free.

Hyundai Motor America
Reduced braking
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Vehicles & Parts
HIGH
NHTSA

Ford Explorer 2025 Recalled for Powertrain PCM Software Issue (25S35)

Ford recalled certain 2025 Explorer SUVs due to a powertrain control module software fault. The PCM may reset while driving, potentially damaging the park system or causing an engine stall. Dealers will perform a free software update after owner letters were mailed on June 6, 2025.

Ford
A damaged
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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
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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
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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
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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
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls CONSTRUX Mini PTC Spacer System Due to Labeling Issues

Orthofix U.S. recalled 61,977 units of the CONSTRUX Mini PTC Spacer System on November 3, 2025. The recall impacts various model numbers due to inconsistent labeling claims. Consumers should stop using the product immediately and follow manufacturer instructions for a refund.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls Ti Spacer System Due to Labeling Issues

Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls CONSTRUX Mini Ti Spacer System Over Labeling Issues

Orthofix U.S. recalled 40,956 units of the CONSTRUX Mini Ti Spacer System on November 3, 2025. Labeling inconsistencies pose potential risks to patients and healthcare providers. Users should stop using the device immediately and follow recall instructions.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Allergy Test Small Recalled for Lack of Premarket Approval (2025)

GET TESTED INTERNATIONAL AB recalled 19 Allergy Test Small devices distributed nationwide in the United States after distribution without premarket approval or clearance. The devices were distributed without FDA clearance. Patients and healthcare providers should stop using this device immediately and contact GET TESTED INTERNATIONAL AB for instructions.

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

GET TESTED INTERNATIONAL AB Recalls Gut Microbiome Test XL

GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.

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

Orthofix Recalls FORZA PTC Spacer System Over Labeling Issues

Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.

Orthofix U.S.
Labeling contains
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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Sperm Test Recall for Premarket Violation (2025)

GET TESTED INTERNATIONAL AB recalled a single Sperm Test device distributed nationwide in the United States on 2025-11-03 due to distribution without FDA premarket approval or clearance. The device was not cleared for sale in the U.S. The company classified the recall as active. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall guidance

GET TESTED INTERNATIONAL AB
Distribution without
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