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Showing 1241–1260 of 11714 results

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Quercetin (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Joint Health Supplement (iFORCE Nutrition) – Unapproved Claims (2025)

Unapproved Drug Claims.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

CADD Medication Cassette (ICU Medical) – bag weld issue (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Moderate

FDAAug 6, 2025Nationwide• ICU Medical Inc.

Reef TA Inserter (SeaSpine) – implant engagement risk (2025)

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

Moderate

FDAAug 6, 2025Nationwide• SEASPINE ORTHOPEDICS CORPORATION

Fish Oil Heart & Brain Supplement (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Adderex XR (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Beta Sitosterol (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Slimaglutide Weight Loss Aid (Hi-Tech Pharmaceuticals) – Misbranded Product (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Uric Control (Top Secret Nutrition) – Unapproved Claims (2025)

Unapproved Drug Claims.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

Class IIILow

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

UroMax Ultra Kit (Boston Scientific) – technical issue (2025)

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

Moderate

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

Encore Advantage Kit (Boston Scientific) – technical issue (2025)

Moderate

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

NephroMax Kit (Boston Scientific) – technical issue (2025)

Moderate

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

Pinnacle Radiation Therapy System (Philips) – image error (2025)

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

Moderate

FDAAug 5, 2025Nationwide• Philips Medical Systems (Cleveland) Inc

Encore 26 Inflation Device (Boston Scientific) – technical issue (2025)

Low

FDAAug 5, 2025Nationwide• Boston Scientific Corporation

t:slim X2 Insulin Pump (Tandem) – software defect (2025)

A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.

Low

FDAAug 5, 2025Nationwide• Tandem Diabetes Care, Inc.