Search

Health Canada is warning consumers not to use Herberex, advertised as an herbal product for sexual enhancement, because it may pose serious health risks. Herberex was authorized as a natural health product, but Health Canada testing found the product…

Internal testing determined that magnesium failed to meet the interference claim as per ifu for the lipemic serum interference. all lots of magnesium osr6189 are affected.   Recall start date: 2021-12-06…

Ventilation stops during clinical use, with waveforms and parameters frozen (not updated). a continuous audible/visual high priority alarm for technical failure 305 is generated. ventilation is suspended until unit is rebooted/replaced. Recall start…

The OER-elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Olympus discovered the detergent and alcohol tank tubing…

When the specific circumstances described below occur, there is a possibility of displaying distorted images along with erroneous measurements. the distortion and measurement difference could affect decisions regarding patient care.…

System overestimates the circumference when the manual trace function is used. the trace circumference value is overestimated; however, the area value is accurate. the issue is present in Sequoia's VA20A/VA25 onward as the VA20A introduced a…

No stability data to support affected lots' shelf life. Affected lots are labelled with the incorrect expiry date found on the container

Contamination with ethylene oxide

Affected lot is labelled with unauthorized claims and ingredients including cetylpyridinium chloride. The product lablel is missing risk statements, the NPN and is incorrectly labelled for use in children.

If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system.…

This face mask was evaluated as "filtration efficiency has not been verified" and it should not be used as a respirator. Recall start date: Dec 13, 2021

The subject product is being removed because Deputy (Ireland) has determined that select lots of global unite stems may have an undersized spigot bore diameter. Recall start date: Dec 13, 2021

The affected lots could contain type DA-2I ethanol.

Medtronic has identified an anomaly with the Stealth Station™ System Cranial Software biopsy depth gauge graphical display which presents during navigation in a cranial biopsy procedure. On June 9, 2021, a complaint was reported to Medtronic that during…

Cardinal Health has initiated a medical device correction for specific production lots of nonabsorbent towels with adhesives manufactured between March 2021 and October 2021 due to varying levels of adhesion. Affected non-absorbent towels are supplied in…