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In the course of post market surveillance activities and our internal quality checks, we identified that the sterile packaging barrier might be damaged for certain batches. Recall Start Date: August 7, 2023

Failure description: several complaints were received where the plug (the one at the opposite side of the tubing) became detached from the In2Flow nasal cannula, causing leakage due to unintentional disconnection of that part. This may result in degraded…

Complaint trending revealed an adverse trend of complaints stating that a LMS surgical operating microscope unexpectedly shut down caused by a defective 24VDC power supply which is used inside the surgical operating microscopes Provido, Proveo 8 and M530…

Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm has been reported due to this issue. Recall start Date:…

Affected lots are missing risk statements on the bottle.

We have become aware of a malfunction with the Hamilton-C2/C3/C1/T1 ventilators when used long term in neonatal patient group. If an affected device is used accumulatively for 91 days in neonatal patient group without a restart of the device, the device…

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…

Zimmer Biomet Canada is initiating a lot specific recall for the Zimmer dermatome blades (00-8800-000-10) in Canada. There have been 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades. The issue would…

 Affected lot may contain the presence of glass particulate.

In normal use, the laser is activated when the user sets the device to the "armed" state and when the foot pedal is depressed in the "armed" state. (the laser is deactivated when it is not in the armed state). However, there were reported events where…

Affected lot may be OOS for related compound CZ RC1

GE Healthcare has become aware of an issue where images from two different patients may be contained in a single study when stored in Centricity Enterprise Archive (EA) and/or Enterprise Archive (EA). This issue could contribute to an adverse patient…

On 05/05/2023 customer in lab in Switzerland identified that two Multichem® S Plus vials were cracked at the bottom and material was leaking from the vial. No actual end-user/patient harm was identified as a result of the cracked vial. Recall start…

It has been determined that transferrin ref OSR6152 lot 2573 does not meet the reagent stability claim stated in the Instructions For Use (IFU). Customers may experience reagent blank shifts, calibration failures, and/or QC failures. Recall start date…

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