cpsc regulated Recalls

2,143 recalls tagged with “cpsc regulated”.

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

Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.

Diasol
Safety and
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Health & Personal Care
HIGH
FDA DEVICE

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.

Diasol
Safety and
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Food & Beverages
HIGH
FDA FOOD

African Food on Wheels Recalls Oven Dried Fish Due to Botulism Risk

African Food on Wheels Inc. recalled 20 boxes of Oven Dried Fish on November 5, 2025. The product poses a high risk of Clostridium botulinum contamination. Customers should not consume the fish and seek a refund immediately.

African Food on Wheels
Clostridium botulinum
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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

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 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

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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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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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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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

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 Recalls Urinary Tract Infection Test Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 40 units of its Urinary Tract Infection 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 and follow the manufacturer's 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

GET TESTED INTERNATIONAL AB Recalls Allergy Test IgE Due to Approval Issues

GET TESTED INTERNATIONAL AB recalled 71 units of its Allergy Test IgE on November 3, 2025. The recall follows distribution without premarket approval, classified as Class II. Patients and healthcare providers should stop using the device immediately.

GET TESTED INTERNATIONAL AB
Distribution without
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