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Showing 1421–1440 of 1734 results

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VentStar Flex 220 (Draeger) – breathing circuit crack (2025)

The potential for cracks forming in the breathing circuit hose.

FDAMar 12, 2025Nationwide• Draeger, Inc.

Novasight Hybrid Catheter (Conavi) – sheath detachment risk (2025)

Due to manufacturing issues there is a potential for the catheter sheath to detach.

FDAMar 12, 2025GA, NJ, NY +1 more• Conavi Medical Inc.

QIAstat-Dx Respiratory Panel (Qiagen) – faulty cartridge (2025)

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

Moderate

FDAMar 12, 2025AL, CA, FL +9 more• Qiagen Sciences LLC

Anesthesia Circuit Kit (Draeger) – breathing circuit crack (2025)

The potential for cracks forming in the breathing circuit hose.

FDAMar 12, 2025Nationwide• Draeger, Inc.

ID Circuit Flex 220 (Draeger) – breathing circuit crack (2025)

The potential for cracks forming in the breathing circuit hose.

FDAMar 12, 2025Nationwide• Draeger, Inc.

Atellica CH CRP (Siemens) – software flagging error (2025)

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

FDAMar 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

PowerPICC Catheters (Bard) – tubing specification issue (2025)

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.

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.

FDAMar 11, 2025Nationwide• 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.

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.

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

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

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

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.

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.

FDAMar 10, 2025Nationwide• Maquet Cardiovascular, LLC

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

The devices are missing the laser marked depth markings.

FDAMar 8, 2025Nationwide• Straumann USA LLC

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

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

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

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

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

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.

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.

FDAMar 7, 2025Nationwide• Ethicon Endo Surgery, LLC

Venue Fit Models R3/R4 (GE Medical Systems) – Battery Fire Risk (2025)

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

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

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

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

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

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