cpsc regulated Recalls

1,716 recalls tagged with “cpsc regulated”.

Health & Personal Care
HIGH
FDA DRUG

DermaSarra Analgesic Recalled Due to Microbial Contamination

DermaRite Industries LLC recalled 249 bottles of DermaSarra External Analgesic on July 17, 2025. The product contains camphor and is contaminated with Burkholderia cepacia. This recall is classified as Class I due to the potential health risks.

DERMASARRA
Microbial Contamination
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Health & Personal Care
HIGH
FDA DEVICE

C.R. Bard Recalls Foley Catheter Trays Over Allergy Risk

C.R. Bard recalled 3,670 Foley catheter trays on July 17, 2025, due to incorrect inserts. Users may confuse materials, leading to allergies or infections. Healthcare providers and patients must stop using these trays immediately.

C.R. Bard
Foley catheter
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Health & Personal Care
HIGH
FDA DEVICE

C.R. Bard Recalls Foley Catheter Tray Over Infection Risk

C.R. Bard Inc issued a recall for 4,300 Foley catheter trays on July 17, 2025. Incorrect inserts lead to potential allergic reactions and infection risk. Healthcare providers and patients must stop using the device immediately.

C.R. Bard
Foley catheter
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Health & Personal Care
HIGH
FDA DEVICE

C.R. Bard Recalls Foley Catheter Trays Over Allergy Risk

C.R. Bard recalled 4,300 Foley catheter trays on July 17, 2025. Incorrect inserts may lead users to misidentify materials, increasing infection and allergic reaction risks. Patients and healthcare providers must stop using the trays immediately and follow recall instructions.

C.R. Bard
Foley catheter
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Health & Personal Care
HIGH
FDA DEVICE

Biofire Defense Recalls FilmArray NGDS Warrior Panel Due to Control Failures

Biofire Defense recalled 130 kits of the FilmArray NGDS Warrior Panel on July 10, 2025. The recall is due to an increased risk of internal control failures when testing positive blood cultures. These failures could delay results and require additional diagnostic workups.

Biofire Defense
FilmArray NGDS
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Health & Personal Care
HIGH
FDA DRUG

Boothwyn Pharmacy Recalls Fluorescein 2% Ophthalmic Solution

Boothwyn Pharmacy recalled 8 vials of Fluorescein 2% Ophthalmic Solution on July 9, 2025. The recall occurred due to the drug being subpotent, posing potential health risks. Consumers should stop using the product immediately and seek guidance from their healthcare provider.

Boothwyn Pharmacy
Subpotent Drug
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recalls Deep Brain Stimulation Devices Over Wire Break Risk

Boston Scientific Neuromodulation recalled 25,260 deep brain stimulation systems on July 8, 2025, due to wire break issues. Users may experience loss of therapy and other serious complications. Patients should stop using the devices immediately and seek further instructions.

Boston Scientific Neuromodulation
Wire break(s)
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Health & Personal Care
HIGH
FDA DRUG

Medline Alcohol Prep Pads Recalled Due to Subpotent Alcohol Levels

Medline Industries recalled approximately 6.67 million alcohol prep pads on July 7, 2025. The recall stems from isopropyl alcohol levels falling below the labeled concentration. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Medline Alcohol Prep
Subpotent Drug-
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Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalls t:slim X2 Insulin Pump Over App Issues

Tandem Diabetes Care recalled 19 t:slim X2 Insulin Pumps on July 3, 2025, due to an app defect. The defect affects devices when set to right-to-left languages, potentially causing incorrect therapy decisions. This may lead to hypoglycemia or hyperglycemia.

Tandem Diabetes Care
an app
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Health & Personal Care
HIGH
FDA DEVICE

North American Rescue Recalls Junctional Emergency Treatment Tool

North American Rescue recalled 552 Junctional Emergency Treatment Tools on July 1, 2025. The device may have a manufacturing defect that compromises its structural integrity. Healthcare providers should stop using it immediately and follow recall instructions.

North American Rescue
Device used
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Health & Personal Care
HIGH
FDA DEVICE

bioMerieux Recalls VITEK 2 AST Test Kits Over False Resistance Risk

bioMerieux recalled 235,269 VITEK 2 Gram-negative AST Test Kits on June 26, 2025. The recall follows potential false resistant results for Colistin with specific bacteria. This may affect patient treatment decisions in multiple countries.

bioMerieux
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Quidel Recalls Dipstick Strep A Test Over False Positive Risk

Quidel Corporation recalled 22,470 Dipstick Strep A Tests on June 17, 2025, due to potential false positive results. The recall affects tests distributed in multiple U.S. states and internationally. Patients and healthcare providers must stop using the device immediately.

Quidel
Dipstick strep
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Health & Personal Care
HIGH
FDA DEVICE

SEDECAL Recalls Mobile X-ray System Over Water Resistance Risks

SEDECAL SA recalled 12 units of its Mobile X-ray system on June 10, 2025, due to water resistance issues. Users must adhere to strict cleaning instructions to avoid equipment damage. The recall affects units distributed in California, Illinois, and New Jersey.

SEDECAL SA
Sedecal sent
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