cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DEVICE

ConvaTec Recalls DuoDERM Dressings Over Foreign Matter Hazard

ConvaTec recalled 80,980 DuoDERM Extra Thin dressings on August 29, 2025, due to potential foreign matter contamination. The dressing is designed for dry to lightly exudating wounds and is suitable for use on sensitive areas. Patients should stop using the product immediately and follow the recall instructions provided by the manufacturer.

ConvaTec
Wound dressing
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 1,019 units of the 1.4mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about potential breaches in the sterile barrier packaging. The product poses a high hazard level due to compromised sterility assurance.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Infusion Sets Due to Leak Risk

Baxter Healthcare recalled 27,072 IV infusion sets on August 29, 2025, due to potential leaks. The affected product, model code 2R8858, may pose significant risks to patients. Healthcare providers and patients should stop using these devices immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 561 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about breaches in the sterile barrier packaging. This could compromise the sterility assurance necessary for medical use.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalls Catheter Over Sterility Risk

Northeast Scientific recalled 795 units of its Turbo-Elite Laser Atherectomy Catheter on August 29, 2025. The recall follows concerns about breaches in the sterile barrier packaging. This issue compromises the sterility assurance of the device.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 49,200 IV solution sets on August 29, 2025. The recall affects products that may leak, posing a risk to patients. Healthcare providers and patients should stop using these devices immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Catheter Recalled Due to Sterility Risk

Northeast Scientific recalled 616 units of its Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall affects model R-417-156 due to potential breaches in the sterile barrier packaging. This issue compromises sterility assurance, posing a high risk to patients.

Northeast Scientific
Potential for
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Food & Beverages
HIGH
FDA FOOD

Herbal Creations Colostrum Powder Recall for Milk Allergen Labeling Error (2025)

Herbal Creations recalls 19,425 kilograms of bulk colostrum powder distributed to 30 US customers after a milk allergen labeling error. The product label does not declare milk as an allergen. Consumers who purchased this product should not consume it and should contact Herbal Creations USA for refund or replacement.

Herbal Creations
Bulk packaged
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 18,720 IV solution sets on August 29, 2025, due to a leak hazard. The recall affects devices distributed across the United States, including all 50 states. Patients and healthcare providers should stop using these devices immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leak Risk

Baxter Healthcare recalled 136,512 IV sets on August 29, 2025, due to potential leaks. The recall affects products distributed nationwide across the United States. Patients and healthcare providers must stop using these devices immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leakage Risk

Baxter Healthcare recalled 473,040 IV solution sets on August 29, 2025, due to a leak hazard. The affected product is the CLEARLINK SYSTEM CONTINU-FLO Solution Set, Product Code 2C8519. Healthcare providers and patients must stop using this device immediately and follow recall instructions.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Solution Set Due to Leak Risk

Baxter Healthcare recalled 8,368 IV Solution Sets on August 29, 2025. The recall stems from potential leaks in the devices, posing a risk to patients. Healthcare providers must stop using the product immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Sets Due to Leakage Risk

Baxter Healthcare recalled 12,720 CONTINU-FLO Solution Sets on August 29, 2025, due to a risk of leakage. The recall affects various states across the U.S. Healthcare providers and patients must stop using the product immediately.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalls Laser Atherectomy Catheter Over Sterility Risk

Northeast Scientific recalled 141 units of the 2.0mm RX Turbo Elite Laser Atherectomy Catheter on August 29, 2025. The recall stems from potential breaches in the sterile barrier packaging, risking patient safety. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls IV Extension Sets Over Leak Risk

Baxter Healthcare recalled 15,552 IV extension sets on August 29, 2025, due to a leak risk. The recall affects products distributed nationwide across 50 states. Healthcare providers and patients must stop using the devices immediately.

Baxter Healthcare
IV sets
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Recalled Lulive 12-Drawer Dresser (front)
HIGH
CPSC

Lulive Recalls Dressers Due to Tip-Over Risk for Children

Lulive recalled 12,000 dressers on August 28, 2025, due to a serious tip-over hazard. The recalled models are unstable if not anchored to the wall, posing risks of injury or death to children. Consumers should stop using the dressers immediately and seek a full refund.

Lulive
The recalled
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Retrieval Balloon Catheter Over Label Error

Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter on August 28, 2025. The product is mislabelled, indicating the wrong position of the skive hole. This recall affects distribution across 15 states in the U.S.

Boston Scientific
The product
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Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Impurity Concerns

Granules Pharmaceuticals Inc. recalled 11,909 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The recall stems from failure to meet impurities and degradation specifications. Healthcare providers and consumers must stop using the product immediately.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Failed Impurities/Degradation
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Health & Personal Care
HIGH
FDA DRUG

Granules Pharmaceuticals Recalls Dextroamphetamine Capsules Over Contamination Risk

Granules Pharmaceuticals Inc. recalled 9,917 bottles of Dextroamphetamine extended-release capsules on August 28, 2025. The product failed impurities and degradation specifications, posing potential health risks. Consumers should stop using the capsules immediately and consult healthcare providers for guidance.

Granules Pharmaceuticals
Failed Impurities/Degradation
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