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Showing 2021–2040 of 3039 results

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GE Versana Ultrasound (GE Healthcare) – Fetal Weight Measurement (2025)

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

FDAMay 16, 2025Nationwide• GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.

Vegetable Singara (South Asian Food) – Undeclared Peanut (2025)

Undeclared Nuts

Contains undeclared peanut

FDAMay 16, 2025

CA, MA, MN +5 more

• South Asian Food Inc.

Q-Stop Suture Device (Drs Vascular) – Unknown Issue (2025)

XXX

FDAMay 16, 2025Nationwide• Drs Vascular, Inc

Broselow Pediatric Tape (SunMed) – Incorrect Zone Information (2025)

The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.

FDAMay 15, 2025Nationwide• SunMed Holdings, LLC

Interventional X-Ray System (Siemens) – Dose Sensor Error (2025)

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

FDAMay 15, 2025Nationwide• Siemens Medical Solutions USA, Inc

ARTIS Angiography System (Siemens) – Dose Sensor Error (2025)

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

FDAMay 15, 2025Nationwide• Siemens Medical Solutions USA, Inc

Beacon Tip Angiographic Catheter (Cook) – Tip Separation (2025)

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

FDAMay 15, 2025Nationwide• Cook Incorporated

Theophylline Extended-Release Tablets (Glenmark) – Dissolution Test Failure (2025)

OOS results reported for the Dissolution (by UV) test.

Class IIModerate

FDAMay 15, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Nutrifill Contact Lens Solution (Contamac) – Sterility Issue (2025)

Contact lens insertion solution may lack sterility.

FDAMay 15, 2025Nationwide• Contamac Solutions, Inc.

BD ChloraPrep Clear (CareFusion) – Packaging Seal Issue (2025)

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Class IIModerate

FDAMay 15, 2025Nationwide• CareFusion 213, LLC

Medline Umbilical Tray (Medline) – Packaging Defect (2025)

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.

FDAMay 15, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Indomethacin Extended-Release Capsules (Amerisource) – Manufacturing Deviation (2025)

cGMP deviations

Class IIModerate

FDAMay 15, 2025Nationwide• Amerisource Health Services LLC

Optisite Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

FEM-FLEX II Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

Airsupra Inhalation Aerosol (AstraZeneca) – Delivery System Defect (2025)

Defective delivery system

Class IIModerate

FDAMay 14, 2025Nationwide• AsttraZeneca Pharmaceuticals LP

FEM-FLEXII Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

Ingenia 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

MR 7700 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Allon 2001 Device (Belmont Instrument) – Temperature Wrap Risk (2025)

An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.

FDAMay 13, 2025Nationwide• Belmont Instrument LLC

Black Kavuni Porridge Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

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