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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…

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

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…

Power wheelchairs with a LINX® Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile. Recall start date: Nov 12, 2021

Smith & Nephew, Inc., has initiated a field action to voluntarily remove three lots of the Acufex Access Advanced Positioning Kits due to the sterilization omission. The affected products were inadvertently shipped to the global distribution center…

Detection of a deformation in the blister pack of the primary packaging during a production control which could lead to a perforation. Secondary packaging is not affected. Recall start date: Nov 19, 2021

All ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination. Multiple products could be affected by manufacturing issues associated with the company's ultrasound gel (such as inappropriate testing of finished product,…

The exterior of the cardiosave hybrid and rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the…