Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
3,609 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Potential contamination with pesticides, haloxyfop and thiamethoxam
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fagron Compounding Services recalled 34,260 bags of Vancomycin HCI Injection across the United States. The recall cites lack of sterility assurance and a blue Break-Off-Part that could detach from the administration port. Healthcare providers and patients should stop using the product immediately and follow manufacturer guidance.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.