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Showing 1141–1160 of 1734 results

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BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

FDAMay 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

FDAMay 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

Bigfoot Unity Diabetes System (Bigfoot) – Insulin Pen Error (2025)

Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.

Moderate

FDAMay 21, 2025Nationwide• BIGFOOT BIOMEDICAL

BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

FDAMay 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

BD BACTEC MGIT 960 PZA Kit (Becton Dickinson) – False Test Results (2025)

BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

FDAMay 20, 2025Nationwide• Becton Dickinson & Co.

ColoSense Test Kit (Geneoscopy) – Plate Control Error (2025)

Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.

FDAMay 20, 2025Nationwide• Geneoscopy, Inc.

My3D Humeral Cup (Onkos Surgical) – Inspection Failure (2025)

Required inspections were not performed on finished product prior to release and distribution.

FDAMay 20, 2025Nationwide• Onkos Surgical, Inc.

Hummingbird EMG Kit (Neurovision Medical) – Packaging Error (2025)

Product packaging contains the wrong part number and kit contents.

FDAMay 19, 2025CA• Neurovision Medical Products Inc

Prima 2mm Eccentrical Adaptor (Limacorporate) – Marking Missing (2025)

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

FDAMay 19, 2025Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Prima 4mm Eccentrical Adaptor (Limacorporate) – Marking Missing (2025)

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

FDAMay 19, 2025Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

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

XXX

FDAMay 16, 2025Nationwide• Drs Vascular, Inc

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.

GE LOGIQ F R3 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.

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

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

Contact lens insertion solution may lack sterility.

FDAMay 15, 2025Nationwide• Contamac Solutions, Inc.

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

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

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

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

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