McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
Zhejiang Kindly Medical Devices Co.
Class I - Dangerous
Potential for difficulty in safety mechanism activation.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
Zhejiang Kindly Medical Devices Co.
Class I - Dangerous
Potential for difficulty in safety mechanism activation.
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Covidien
Class I - Dangerous
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.
McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
Zhejiang Kindly Medical Devices Co.
Class I - Dangerous
Potential for difficulty in safety mechanism activation.
Class I - Dangerous
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.
Class I - Dangerous
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Aspiration Syringe Kit, REF: MVSK60
MICROVENTION
Class I - Dangerous
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Class I - Dangerous
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.
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Becton Dickinson & Company
Class I - Dangerous
Holes in product packaging impacts package integrity and may compromise sterility.
C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Class I - Dangerous
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.
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Intuitive Surgical
Class I - Dangerous
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing