Prophet Premium Blends, LLC Recalls

FDAJun 27, 2024AL, AK, AZ +48 more• Prophet Premium Blends, LLC

Diamond Shruumz Chocolate Bars (Prophet Premium Blends) – muscimol toxicity (2024)

Toxic levels of muscimol

FDAJun 27, 2024AL, AK, AZ +48 more• Prophet Premium Blends, LLC

Diamond Shruumz Chocolate Bars (Prophet Premium Blends) – muscimol toxicity (2024)

Toxic levels of muscimol

FDA

1...164 165166167 168...1884

Page 166 of 1884Next

Jun 27, 2024

AL, AK, AZ +48 more

• Prophet Premium Blends, LLC

Diamond Shruumz Chocolate Bars Dark (Prophet Premium Blends) – Muscimol Toxicity (2024)

Toxic levels of muscimol

FDAJun 27, 2024AL, AK, AZ +48 more• Prophet Premium Blends, LLC

Diamond Shruumz Infused Cones Chocolate Chip (Prophet Premium Blends) – Muscimol Toxicity (2024)

Toxic levels of muscimol

FDAJun 27, 2024AL, AK, AZ +48 more• Prophet Premium Blends, LLC

CADD Medication Cassette Reservoir (Smiths Medical) – Weld Joint Weakness (2024)

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

ARTIS Angiography System (Siemens) – Detector Potential Issue (2024)

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

FDAJun 26, 2024Nationwide• Siemens AG/Siemens Healthcare GmbH Rittigfeld 1 Forchheim Germany

2025 Thomas Built SAF-T-LINER C2 (Thomas) – Emergency Exit Concern (2024)

Daimler Trucks North America, LLC (DTNA) is recalling certain 2023-2025 Thomas Built Buses Saf-T-Liner C2 and 2024-2025 Thomas Built Buses Saf-T-Liner C2 Jouley school buses. The audible emergency warning alarm sounds may not activate when the emergency hatch or window is open. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."

NHTSAJun 26, 2024Nationwide• THOMAS BUILT BUSES

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

CADD-Solis Battery Pack (Smiths Medical) – Adapter Damage Risk (2024)

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

FDAJun 26, 2024Nationwide• Smiths Medical ASD, Inc.

DVOT Multi-Pathogen Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

ENT Reservoir Kit (Smiths Medical) – Weld Joint Weakness (2024)

FDAJun 26, 2024Nationwide• Smiths Medical ASD Inc.

BD Insyte Autoguard IV Catheter (BD) – Tubing Hole Risk (2024)

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

FDAJun 26, 2024IL• Becton Dickinson Infusion Therapy Systems, Inc.

Bovine Collagen Peptide Powder (Nanjing Nutrabuilding) – Salmonella Risk (2024)

Salmonella

Potential Salmonella contamination.

Class IIModerate

FDAJun 26, 2024WI• NANJING NUTRABUILDING BIO TECH C

Sevelamer Carbonate Suspension (Dr. Reddy's) – Labeling Error (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

Class IIILow

FDAJun 26, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

DVOT SARS-CoV-2 Antigen Test (Feng Chun Yuan) – Unauthorized Sales (2024)

The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

FDAJun 26, 2024Nationwide• FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN) CO., LTD No. 1304 Science And Technology Innovation Park, Shajing Dahong Shenzhen China

Potassium Chloride Capsules (Amerisource) – Dissolution Failure (2024)

Failed Dissolution Specifications

FDAJun 25, 2024Nationwide• Amerisource Health Services LLC

HeartMate 3 System Controller (Thoratec) – UI Membrane Risk (2024)

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

FDAJun 25, 2024AL, AZ, AR +39 more• Thoratec LLC

Tech Medical Endo Retrieval Pouch (Unimax) – Tube Fall Risk (2024)

The tube may fall into the surgical site during the grasping process.

FDAJun 25, 2024Nationwide• UNIMAX MEDICAL SYSTEMS INC 8F-2, NO

NIM Vital Nerve Monitoring System (Medtronic) – False Negative Risk (2024)

Potential for false negative response on the NIM Vital Nerve Monitoring System