🏥 Medical Devices • 15,809 recalls
Smith & Nephew, Inc. Endoscopy Division
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm
Under certain circumstances, the Left eye image may be saved as the Right eye image.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic.
Waldemar Link GmbH & Co. KG (Corp. Hq.)
The trial stems were manufactured using the wrong design.
Siemens Healthcare Diagnostics
The ADVIA 120 optics cover or hood is located on the very top of the ADVIA 120 analyzer. When the optics cover is raised, it is supported by two gas struts (SMN 10309266) attached to the cover on the left and right sides. Over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. This could cause the cover to fall during maintenance procedures.
PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative.