Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
Olympus Corporation of the Americas
Class I - Dangerous
Software malfunction that results in incorrect generation or display of error codes.
Class I - Dangerous
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Class I - Dangerous
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Stryker Sustainability Solutions
Class I - Dangerous
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Class I - Dangerous
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Class I - Dangerous
Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.
Class I - Dangerous
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.
Sterility: Due to a potential incomplete seal on the outer sterile package.
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.