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Showing 1101–1120 of 1734 results

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Altivate Reverse Torx Screw (Unknown) – Labeling Size Mismatch (2025)

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

FDAMay 28, 2025CO, FL, IL +15 more

Philips X7-2t Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips VL13-5 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

Low

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips S7-2 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

CDI OneView BPM Probe (Terumo) – Temperature Measurement Error (2025)

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

FDAMay 28, 2025Nationwide• Terumo Cardiovascular Systems Corporation

Philips C5-1 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Azurion R1.x and R2.x Systems (Philips) – Communication Software Issue (2025)

Laceration Risk

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

FDAMay 28, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Philips S7-3t Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips L12-3 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips V6-2 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

KWIK-STICK Control Kit (Microbiologics) – Incorrect Microorganism (2025)

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

FDAMay 27, 2025Nationwide• Microbiologics Inc

O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

FDAMay 27, 2025Nationwide• Medtronic Navigation, Inc.-Boxborough

EPIONE Model 30-0001 (Unknown) – Software Guidance Error (2025)

Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

FDAMay 23, 2025Nationwide

Discovery MR750w 3.0T (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

Medline Convenience Kits (Medline) – IV Catheter Issue (2025)

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

FDAMay 23, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Omnipod 5 Insulin System (Unknown) – Decimal Separator Issue (2025)

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

FDAMay 23, 2025Nationwide

MicroMyst Applicator (Integra) – Sterility Concern (2025)

Lack of sterility assurance.

FDAMay 23, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

SIGNA Architect (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

Apex Knee System (Corin Medical) – Packaging Integrity Issue (2025)

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

FDAMay 23, 2025Nationwide• CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom

Jewel Precision Sterilization Container (Jewel Precision) – FDA Clearance Problem (2025)

The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.

FDAMay 23, 2025TN• Jewel Precision Sheet Metal & Machining Co, Inc.

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