Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
Unapproved design changes to the products outside of the 510(k) clearance.
Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Unapproved design changes to the products outside of the 510(k) clearance.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639
Medline Industries
Class I - Dangerous
Unapproved design changes to the products outside of the 510(k) clearance.
Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Class I - Dangerous
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Integra LifeSciences Corp. (NeuroSciences)
Class I - Dangerous
Software issue that renders the touch screen unresponsive.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Medline Industries
Class I - Dangerous
Unapproved design changes to the products outside of the 510(k) clearance.
Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Class I - Dangerous
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Class I - Dangerous
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.