🏥 Medical Devices • 6,839 recalls
Beaver Visitec International
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Covidien
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
Zhejiang Kindly Medical Devices Co.
Potential for difficulty in safety mechanism activation.
Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
MICROVENTION
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
Becton Dickinson & Company
Holes in product packaging impacts package integrity and may compromise sterility.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
Due to misbranded products shipped to customers.
Due to misbranded products shipped to customers.
Intuitive Surgical
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing