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The most recent lot of BC-3D distributed, lot b1122, normal level may exhibit hemolysis or deterioration due to a microbial contamination. Recall start date: December 5, 2022

Following an internal product review, Stradis identified certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.  Use of the kits that do not maintain…

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier…

Multiple complaints for the TON3015 were received for "needle protector fully dislodged / hole in pouch" due to exposed sharp. Recall start date: August 10, 2021

Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube.…

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

PLS set itself is delivered sterile and compliant, this issue relates to maintaining sterility after opening the pls set and removal of components (5) and (14) from the pls set tray for use in a later stage of extracorporeal circulation application.…

Instructions for use Z24357US, Revision BA inadvertently referred to the incorrect cleaning brush model in the Detergent Cleaning instructions. The affected instructions for use were posted online and accompanied products between April 18 and April 29,…

Investigation conducted at the manufacturing site identified deviations at the catheter hub that could lead to leakage of the product. Recall start date: August 25, 2022

Cook Medical identified that devices from the affected device lots may have a breach of the chevron seal of the packaging. therefore, the sterility of affected devices may be compromised. Recall start date: August 16, 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…

BD is conducting a voluntary medical device recall for multiple lots of the BD Posiflush SF (sterile field) saline flush syringe 10ml. This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially…

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…

Potentially non-sterile intravascular device shipped to customers. Recall start date: May 30, 2022

Stryker has identified a nonconformance relating to the Evolve Triad Plate Cutter provided in the Evolve Triad Instrument Kit (4951kit1). Specifically, the plate cutter is unable to meet sterilization requirements when it is sterilized in a double…