TruSignal Ear Sensor, REF TS-E-D; Oximeter
GE Healthcare Finland Oy
Class I - Dangerous
There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Class I - Dangerous
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Class I - Dangerous
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045151
T.A.G. MEDICAL PRODUCTS CORPORATION
Class I - Dangerous
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Waldemar Link GmbH & Co. KG (Mfg Site)
Class I - Dangerous
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Megadyne Medical Products
Class I - Dangerous
Firm has received reports of patient burns in surgical procedures where device was used.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Ellex Medical Pty
Class I - Dangerous
When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Randox Laboratories
Class I - Dangerous
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.