cpsc regulated Recalls

2,056 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Liquid Concentrate for Dialysis Due to Safety Concerns

Diasol recalled 74,400 gallons of its Liquid Concentrate for Bicarbonate Dialysis on November 5, 2025. The recall stems from concerns about the safety and efficacy of the dialysis acid concentrate. Patients and healthcare providers should stop using the product immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 186,000 containers of its 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 and follow recall instructions.

Diasol
Safety and
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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

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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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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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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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 6 Food Intolerance Test Large Units for Premarket Issue (2025)

GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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

Orthofix Recalls FIREBIRD SI Fusion System Over Labeling Issues

Orthofix U.S. recalled 19,431 units of its FIREBIRD SI Fusion System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Affected models include multiple sizes of FIREBIRD SI Screws, sold worldwide.

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

GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Recalled for 3 Units in 2025

GET TESTED INTERNATIONAL AB recalled 3 units of its Food Sensitivity Test Large sold nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Consumers should stop using it and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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

GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (2025)

GET TESTED INTERNATIONAL AB recalled 8 Fructose Intolerance Test devices distributed nationwide in the United States. The recall cites distribution without FDA 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
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Health & Personal Care
HIGH
FDA DEVICE

Orthofix Recalls PTC Spacer Systems Over Labeling Issues

Orthofix U.S. LLC recalled 13,317 PTC Spacer Systems on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple model numbers sold worldwide, including in the U.S. The company advises immediate cessation of use and communication with healthcare providers.

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

GET TESTED INTERNATIONAL AB Candida Test Recalled for 166 Units in 2025

GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the manufacturer.

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

GET TESTED INTERNATIONAL AB D-Dimer Test Recall for 1,218 Units (2025)

GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all recall instructions.

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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