Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

High

FDAMar 11, 2025Nationwide• Bard Access Systems, Inc.

BD Pyxis MedBank (CareFusion) – dispensing calculation error (2025)

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

Moderate

FDAMar 11, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank CUBIE (CareFusion) – restocking software issue (2025)

Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.

Moderate

FDAMar 11, 2025AL, AZ, CA +29 more• CareFusion 303, Inc.

BD Pyxis MedBank (CareFusion) – restocking software issue (2025)

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

Moderate

FDAMar 11, 2025Nationwide• CareFusion 303, Inc.

Philips DXR System (Philips) – collimator fall risk (2025)

Potential for collimator to fall as a result of incorrect installation.

Moderate

FDAMar 10, 2025Nationwide• Philips North America Llc

NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

Moderate

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

VH-3010 Power Supply (Maquet) – resistor issue (2025)

Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the Jaws of the HemoPro 2 to not adequately head up.

Moderate

FDAMar 10, 2025Nationwide• Maquet Cardiovascular, LLC

TLX/TLC Implant Driver (Straumann) – depth marking missing (2025)

The devices are missing the laser marked depth markings.

Low

FDAMar 8, 2025Nationwide• Straumann USA LLC

PDS Plus Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

PDS II Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

Ethibond Excel Suture (Ethicon) – needle curing problem (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

PROLENE BLU 18IN (Ethicon Endo Surgery) – Manufacturing Curing Issues (2025)

Identified curing issues with the silicone during the needles manufacturing process.

Moderate

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

Low

FDAMar 6, 2025PA• Fisher Diagnostics

Venue Go Models R2/R3 (GE Medical Systems) – Battery Fire Risk (2025)

Fire/Burn Risk

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

High

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

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