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Search: "lead"

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Showing 21–40 of 1051 results

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3 B Cookware 5 (India's Fine Foods) – Leachable Lead (2025)

Potential contamination due to leachable lead.

Class II

FDAOct 28, 2025CA, WA• India's Fine Foods, Inc.

3 B Cookware (India's Fine Foods) – Lead Contamination (2025)

Potential contamination due to leachable lead.

Class II

FDAOct 28, 2025CA, WA• India's Fine Foods, Inc.

CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)

Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

FDAOct 21, 2025Nationwide• Medtronic MiniMed, Inc.

Cinnamon Powder (Haitai, Inc.) - Elevated Lead Levels (2025)

Elevated levels of lead in Cinnamon powder.

Class II

FDAOct 17, 2025Nationwide• Haitai, Inc.

Cinnamon Powder (Homeneeds) - Elevated Lead Levels (2025)

Elevated levels of lead. FDA ground cinnamon sample was found to contain 2.92 mg/kg.

Class II

FDAOct 16, 2025IN, WA• Homeneeds Inc

Anesthesia Circuit Kit (Unknown) – Circuit Leak Hazard (2025)

Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

FDAOct 10, 2025Nationwide

Robotic Surgery Kits (Unknown) – Anesthesia Circuit Leak (2025)

FDAOct 10, 2025Nationwide

Breast Hernia Kit (Unknown) – Anesthesia Circuit Leak Risk (2025)

FDAOct 10, 2025Nationwide

Anesthesia Circuit Kits (Unknown) – Circuit Leak Hazard (2025)

FDAOct 10, 2025Nationwide

Surgical Convenience Kits (Unknown) – Anesthesia Circuit Leak (2025)

FDAOct 10, 2025Nationwide

Convenience Kits (Unknown) – Anesthesia Circuit Leak Risk (2025)

FDAOct 10, 2025Nationwide

Orthopedic Surgery Kits (Unknown) – Anesthesia Circuit Leak (2025)

FDAOct 10, 2025Nationwide

Roshni Cinnamon Powder (Singh Trading) – heavy metals (2025)

Product may contain elevated levels of lead and chromium.

Class II

FDAOct 9, 2025FL, MD, NC +2 more• Singh Trading Inc. DBA Roshni Foods

Quantum Intersegmental Table (Pivotal Health) – Heat Function Risk (2025)

The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.

FDAOct 9, 2025Nationwide• Pivotal Health Solutions, Inc.

ACUSON ACUNAV Catheter (Sterilmed) – Reprocessing Integrity Risk (2025)

Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

FDAOct 8, 2025Nationwide• Sterilmed, Inc.

ACUSON Imaging Catheter (Sterilmed) – reprocessing cycles (2025)

FDAOct 8, 2025Nationwide• Sterilmed, Inc.

Ground Ginger 16 oz (Eagle Spice) – Elevated Lead Levels (2025)

Contains elevated levels of lead (Pb)

Class II

FDAOct 7, 2025CT, NJ, NY +1 more• Eagle Spice and Extract Co., Inc.

TRUE METRIX Blood Glucose Meter (Trividia) – LCD display issues (2025)

Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

FDAOct 7, 2025Nationwide• Trividia Health, Inc.

SimplyGo Mini Battery Kit (Philips) – charging defect (2025)

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

FDAOct 7, 2025Nationwide• Philips Respironics, Inc.

MAGNETOM Cima.X Upgrade (Siemens) – ice blockage potential (2025)

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAOct 1, 2025CA• Siemens Medical Solutions USA, Inc

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