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Philips Respironics has detected environmental contamination (e.g. External dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental contaminants can lead to buildup of particulate on…

Lot w92761 was not sent for sterilization but it was released for sale as non-sterile product labelled as sterile. Recall start date: October 28, 2022

Baxter Corporation is issuing an urgent medical device recall for all non-expired lots of Self-Righting Luer Slip And Luer Lock Tip Caps listed due to the potential of the packaging seal not maintaining a sterile barrier for the tip caps. Recall start…

During the manufacturing process, there is a slight risk of the formation of a hole in the sterile packaging which typically forms near the pre-sealed area at the bottom of the sterile packaging of the Yelloport Elite Universal Seals. Recall start…

Mold was found in lot Y591676 of the product. Two species of mold were identified that could pose a potential health risk to users. Recall start date: May 3, 2022

Radiometer has been performing integrity testing of the Pico50 arterial blood sampler packaging material. Integrity studies included sterility testing to show that the integrity of the sterile barrier system is intact. In the 24 month real time study, 1…

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…