Medline

Medline Industries has recalled multiple sterile surgical kits and procedure trays due to calibration problems in the sterilization equipment used to manufacture them. Although the products went through normal sterilization cycles, the equipment calibration issues may have reduced the sterility assurance level of these kits. No injuries have been reported.

Medline identified calibration problems with the equipment that sterilizes and packages certain Lithotomy Pack surgical kits. Although the kits went through sterilization cycles, the equipment issues may have affected whether the products are properly sterile. No injuries have been reported.

Medline Industries recalled multiple surgical kits used in hospitals and surgical centers because equipment used to sterilize and package them had calibration problems. While the kits went through sterilization cycles, the calibration issues may have affected whether they are truly sterile. No injuries have been reported.

Medline Industries identified calibration problems in the equipment used to sterilize and package two models of endoscopy convenience kits. The kits were processed through sterilization cycles, but the equipment calibration issues may have affected whether the devices are truly sterile. No injuries have been reported.

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline identified calibration problems in equipment used to sterilize and package over 70 different surgical kits used in head, neck, ENT, and other procedures. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility assurance level, meaning they may not be sterile.

Medline Industries identified calibration problems with equipment used to sterilize and package certain Dental Pack kits (Model DYNDA3003). While the products went through sterilization cycles, the calibration issues may have affected whether the packages remain sterile. This recall affects specific lot numbers manufactured between 2022 and 2024.

Medline has recalled multiple surgical and biopsy convenience kits due to calibration problems with sterilization equipment. While the kits went through standard sterilization cycles, the equipment calibration issues may have affected whether the kits are truly sterile. No injuries have been reported.

Medline identified calibration problems with sterilization equipment used to process over 24 models of surgical procedure kits and central line trays. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility. No injuries have been reported.

Medline identified calibration problems in the equipment used to sterilize and package cardiac and vascular surgical convenience kits. Although the kits went through sterilization cycles, the calibration issues may have affected their sterility assurance level. No injuries have been reported.

Medline Industries recalled multiple surgical procedure kits used in cardiac and vascular procedures due to calibration problems with sterilization equipment. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility, potentially exposing patients to contamination risks.

Medline discovered calibration problems with equipment used to sterilize certain surgical and catheterization convenience kits. While the kits went through sterilization cycles, the equipment issues may have affected how well they were sterilized. No injuries have been reported.

Medline Industries recalled its Basic Nerve Block Tray with Linen (Model PAIN0150C) because equipment used to sterilize and package the devices had calibration problems. While the products went through sterilization cycles, the calibration issues may have reduced the sterility assurance of these medical trays.

Medline has recalled several medical convenience kits used for pain management and nerve block procedures due to calibration problems with sterilization equipment. While the products went through sterilization cycles, calibration issues could affect whether the devices are truly sterile. No injuries have been reported.

Medline has recalled certain tracheostomy convenience kits and Trach Tote bags due to calibration problems with the sterilization equipment used during manufacturing. While the products went through sterilization cycles, the calibration issues may have affected their sterility. No injuries have been reported.

Medline Industries identified calibration problems with equipment used to sterilize and package two types of surgical convenience kits: Ancillary Pack-LF and Open Heart Anesthesia ICC-A. Although these products went through sterilization cycles, the equipment calibration issues may have affected whether the kits are fully sterile. This recall affects 551 units distributed nationwide.

Medline Industries is recalling 23 models of IV administration and extension sets because the male connectors may leak, crack, or break during use under certain conditions. This could cause delays in treatment, blood loss, infection, air embolism, or patients not receiving the correct medication dose.

Medline Industries is recalling specific lots of Mercy Circumcision Tray kits because the BD ChloraPrep Triple Swabsticks inside may have open or compromised seals on their packaging. This could affect the sterility of the applicators before use. No injuries have been reported so far.

Medline is recalling specific lots of sterile resuture packs (SKU DYNDL1980A) because the BD ChloraPrep swabsticks inside may have broken seals on their packaging. An open seal could allow the swabs to become contaminated. No injuries have been reported.

Medline is recalling nine different medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or damaged seals, which could allow contamination. About 8,445 kits are involved nationwide.

Medline is recalling specific lots of its blood culture kits because the BD ChloraPrep Triple Swabsticks inside may have damaged or open packaging seals. This could allow the applicators to dry out or become contaminated before use. The affected lots are 25EBU508 and 25EBE330.

Medline is recalling specific lots of suture removal kits that contain BD ChloraPrep Triple Swabsticks with potentially open or compromised packaging seals. An open seal on the applicators could allow contamination of the sterile product before use. No injuries have been reported.

Medline is recalling two medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially open or compromised packaging seals. The affected kits are the POWERGLIDE DRESSING CHANGE KIT (SKU DYNDH1576, Lot 25EBP737) and CENTRAL LINE TRAY W/ CHLRP SWB (SKU RWM-DC57KC, Lot 25EBE082). An open seal could allow the sterile applicator to become contaminated.

Medline Industries is recalling 11 different medical kits that contain BD ChloraPrep Triple Swabsticks with potentially compromised packaging seals. The affected applicators may have open or broken seals, which could affect the sterility of the product. No injuries have been reported so far.

Medline is recalling eight types of medical convenience kits that contain BD ChloraPrep Triple Swabsticks with potentially opened or compromised seals. The affected kits are used in hospitals and medical settings for procedures involving central lines and ports. No injuries have been reported.

Medline Industries is recalling specific lots of Pediatric Cath Securement Kits (SKU DYNDC3108) because the BD ChloraPrep Triple Swabsticks inside may have open or compromised packaging seals. An open seal could allow the applicators to dry out or become contaminated before use.

Medline Industries is recalling specific lots of adult catheter securement kits (SKU DYNDC3109) because the BD ChloraPrep Triple Swabstick applicators inside may have broken seals on their packaging. This could allow the sterile applicator to become contaminated.

Medline Industries recalled specific lots of its Anesthesia Artline Pack kits because the BD ChloraPrep Triple Swabsticks inside may have open or compromised seals on the applicator packaging. An open seal could allow the sterilizing solution to dry out or become contaminated before use. No injuries have been reported.

Medline Industries is recalling certain lots of reprocessed Siemens ACUSON AcuNav ultrasound catheters because they may contain small particles of leftover material from reprocessing. If used, these particles could cause inflammation, infection, or blood clots that may lead to serious complications including stroke or pulmonary embolism.

Certain lots of reprocessed Biosense Webster SOUNDSTAR eco diagnostic ultrasound catheters may contain small particles of leftover material from manufacturing. If used, these particles could cause blood clots, infection, or other serious complications including stroke or lung embolism.