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Olympus found that certain lots of the CV-190 do not start up properly and as a result, the image from the endoscope is not displayed when the operations listed below are performed because parts that deviated from the specification were assembled into…

The shaft and tip component of the Universal Joint Screwdriver was manufactured with the incorrect raw stainless steel material. Recall start date: September 1, 2023

Siemens Healthcare will be informing customers about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within the headband of the over-ear headphones listed below when used during head examinations with the Magnetom MRI…

Arjo has observed an increasing complaint trend on the following failure modes occurring on Arjo medical beds assembled with the Indigo modules: unanticipated device self-acceleration while being operated by a caregiver, unexpected movement without any…

Stryker has discovered the potential for the Triathlon Fixation Peg to be missing the hex hole feature preventing the peg from assembling with the slip torque handle. Recall start date: August 21, 2023

These unauthorized nitrile medical examination gloves were distributed by Frontier Dental Supply Inc. between March 15, 2022 to December 24, 2022. These products, which were intended to European market, entered Canada without authorization from Health…

The calibration of the force sensor used to detect occlusions may shift over time. If the force sensor calibration shift is large enough, the pump will display a system failure alarm (including force sensor BGND test, force sensor bridge test, or force…

The following malfunctions and nonconformances were observed during Trexo lab-testing and Trexo design reviews of the device, Resulting in this voluntary device recall and proposed field correction. Electromagnetic (EM) radiation levels above threshold (…

A single lot (74M2001125) of the one-way valve (part #50412 (pack of 5)) utilized with the Inomax dsir plus is being recalled. The one-way valve is used to prevent reverse flow into the Inomax dsir injector module from high frequency ventilators and…

Ethicon received seven complaints for one lot of undyed PDS™ II sutures regarding low tensile strength. Internal testing on returned product from this lot confirmed that some PDS™ II sutures from this lot did not meet Ethicon's tensile strength…

Abbott has received complaints from patients who are unable to exit MRI mode, as their patient controller has lost the ability to connect or communicate with their IPG while in MRI mode. Abbott sent a customer communication on 2023-07-21 to remind health…

Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of Trigen Trochanteric Antegrade nail due to a packaging error. Recall start date: July 24, 2023

Smith & Nephew Medical Limited has initiated a field action to voluntarily remove certain batches of no-sting skin-prep wipes and no-sting skin-prep swabs due to a manufacturing error resulting in the presence of acetic acid causing a vinegar-like…

Twelve (12) units of LBGEM05, lot # 0523001 was sent to Canadian customer.  This lot has a recently updated component (syringe stopper with fluorotek barriers) which requires a significant change notification prior to distribution. Recall start…

Stryker has identified a nonconformance in a specific lot of Aequalis® Flex Revive® Assembly Screws. Specifically, a comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis® Flex Revive® Assembly Screws 0mm…