Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Wilson-Cook Medical
Class I - Dangerous
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Arrow International
Class I - Dangerous
The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Class I - Dangerous
The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
Class I - Dangerous
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class I - Dangerous
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
Potential for the sterile packaging to be compromised
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
Class I - Dangerous
The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.
Class I - Dangerous
Curity All Purpose Sponges were not sterilized and distributed
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
Alcon Research Laboratories
Class I - Dangerous
Potential for the optical head to detach from the stand due to the lack of thread adhesive.
Class I - Dangerous
The product is contaminated with Pseudomonas.
Class I - Dangerous
A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.
Class I - Dangerous
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.