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Showing 5881–5900 of 11714 results

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Cranial Drill 6.00mm (Globus) – Sterility Packaging Concern (2023)

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

FDADec 11, 2023Nationwide• Globus Medical, Inc.

BrainFeedback Pro 2 Device (Ronan) – Performance Documentation Issue (2023)

Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

FDADec 11, 2023Nationwide• RONAN MEDICAL LLC

Flow-e Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Laceration Risk

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

High

FDADec 11, 2023Nationwide• Getinge Usa Sales Inc

ENDOPATH Echelon Reloads (Ethicon) – Staple Line Formation Risk (2023)

There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

FDADec 11, 2023Nationwide• Ethicon Endo-Surgery Inc

Nystatin Powder 500 MU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Nystatin Powder 5 BU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Sertraline Tablets (Legacy) – Product Comingling Risk (2023)

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Class IIModerate

FDADec 11, 2023AR, CA• Legacy Pharmaceutical Packaging LLC

Nystatin Powder 2 BU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Nystatin Powder 150 MU (Fagron) – Incorrect Strength Label (2023)

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Class IIModerate

FDADec 11, 2023Nationwide• Fagron, Inc

Flow-i C30 Anesthesia System (Getinge) – Cybersecurity Vulnerability (2023)

Laceration Risk

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

FDADec 11, 2023Nationwide• Getinge Usa Sales Inc

WAVi Research EEG System (WAVi) – Research Study Closure (2023)

Following an FDA-issued Warning Letter, the firm requested return of their research EEG system components due to the closing of their research study.

FDADec 8, 2023AL, AZ, AR +28 more• WAVi Co.

Duodenovideoscope Distal Cover (Olympus) – Detachment Risk (2023)

Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

FDADec 8, 2023Nationwide• Olympus Corporation of the Americas

XScribe Cardiac Stress System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Mega Soft Universal Plus Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Azurion FlexArm System (Philips) – Connectivity Loss (2023)

Loss of connectivity between the FlexArm and the Table due to a software issue.

FDADec 8, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

XScribe Cardiac Testing System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

Mega Soft Universal Plus Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Mega Soft Universal Electrode (Megadyne) – Burn Injury Risk (2023)

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Q-Stress Cardiac System (Baxter) – ECG Reading Distortion (2023)

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

FDADec 8, 2023Nationwide• Baxter Healthcare Corporation

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