Delaware recalls

Centinel Spine's Prodisc C SK cervical disc replacement devices were labeled as 6mm but actually contained 5mm products. This mislabeling affects 20 units distributed across eight states. The size difference could affect surgical fit and patient outcomes.

Medline Industries identified calibration problems with equipment used to sterilize and package certain surgical packs. While the packs went through the standard sterilization process, the equipment issues may have affected their sterility. This recall affects specific lot numbers of Universal UltraGard and Shoulder Drape Pouch surgical packs.

Medline has recalled multiple models of surgical gowns due to calibration problems with sterilization equipment. While the gowns went through sterilization cycles, equipment calibration issues may have affected their sterility. No injuries have been reported.

Medline Industries recalled multiple surgical drape products due to calibration problems with sterilization equipment. While the drapes went through sterilization and packaging, equipment calibration issues may have compromised their sterility. No injuries have been reported.

Medline discovered that equipment used to sterilize and package certain arthroscopy surgical kits had calibration problems. While the kits went through sterilization, the equipment issues may have affected whether the products met required sterility standards. No injuries have been reported.

Medline has recalled multiple surgical convenience kits used in orthopedic and neurosurgery procedures due to calibration issues with sterilization equipment. While the kits went through sterilization cycles, equipment calibration problems may have affected their sterility assurance. No injuries have been reported.

Medline Industries identified calibration problems with equipment used to sterilize and package certain surgical and eye surgery convenience kits. Although the kits went through sterilization cycles, the calibration issues may have affected how reliably the sterilization worked. No infections or injuries have been reported.

Medline Industries recalled multiple surgical convenience kits used in hospitals and surgical centers because equipment used to sterilize and package them had calibration problems. Although the kits went through sterilization cycles, the calibration issues may have affected their sterility. No injuries have been reported.

Medline Industries recalled multiple surgical convenience kits used in gynecological and other procedures because of calibration problems in the sterilization equipment. Although the kits went through standard sterilization cycles, the equipment issues may have compromised their sterility.

Medline Industries recalled multiple models of C-section surgical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization cycles, equipment calibration issues may have compromised their sterility. No injuries have been reported.

Medline Industries identified calibration problems with sterilization equipment used to process certain urology surgical kits. While the products went through sterilization cycles, the equipment issues may have affected whether the devices are truly sterile. This affects five models of urology kits distributed nationwide.

Medline has recalled multiple surgical convenience kits used in gynecological, urological, and other surgical procedures due to calibration problems with sterilization equipment. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility assurance level, potentially compromising the sterility of the devices.

Medline Industries identified calibration problems with equipment used to sterilize and package obstetric and gynecology convenience kits. While the kits went through sterilization cycles, the equipment calibration issues may have affected whether the products met required sterility standards. No injuries have been reported.

Medline recalled multiple neurological surgical kits due to calibration problems in the sterilization equipment used to process them. Although the kits went through the standard sterilization process, calibration issues may have reduced the sterility assurance level of the products.

Medline Industries has recalled certain Chest/Breast-LF Convenience Kits (Model DYNJ83950) 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 meet required sterility standards. No injuries have been reported.

Medline identified calibration problems with sterilization equipment used to process certain LVAD driveline and central line dressing change trays. These issues may have affected the sterility of the devices, even though they went through standard sterilization cycles. The recall affects specific lot numbers manufactured between 2020 and 2025.

Medline has recalled certain batches of its Admit Kit (model DYKA1343A) due to calibration problems with the sterilization equipment used to package them. While the kits went through sterilization, the equipment issues may have affected how well they stayed sterile. No injuries have been reported.

Medline identified calibration problems with equipment used to sterilize and package two models of convenience kits: the Drape Pack (Model DYNJ35363A) and Sick Kids-General Custom Split (Model SPTPCD10005). While the products went through sterilization cycles, the calibration issues may have affected whether the products remained properly sterile.

Medline Industries identified calibration problems with equipment used to sterilize and package certain PPE Convenience Kits. Although the products went through sterilization, the equipment issues may have affected how well the sterility protection worked. Multiple lot numbers from 2021 through 2025 are involved.

Medline identified calibration problems with equipment used to sterilize and package their triple lumen insertion kits (Model DYNDM1031A). While the kits went through sterilization, the calibration issues may have affected whether they are truly sterile. This affects 15 units with lot number 23EBM150.

Medline identified calibration problems in the equipment used to sterilize and package DRAPE PACK-CHOICE kits (Model DYNJ63118A). While the products went through sterilization cycles, the equipment calibration issues may have affected whether the products are properly sterile.

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 has recalled three models of burn care convenience kits because equipment used to sterilize and package them had calibration problems. While the products went through sterilization cycles, the calibration issues may have affected whether the kits are properly sterile. No injuries have been reported.

Medline identified calibration problems with the equipment used to sterilize and package certain Convenience Kits (Model DYNJ50806L, Lot 23FBK937). While the products went through sterilization, the equipment calibration issues may have affected whether the devices are properly sterile. This could potentially compromise the safety of the medical devices.

Medline has recalled certain LVAD driveline trays and central venous insertion kits due to calibration problems with sterilization equipment. These devices may not meet required sterility standards, even though they went through sterilization cycles. No injuries have been reported.

Medline has recalled six types of surgical and medical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization and packaging processes, the calibration issues may have compromised the sterility of the products. 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 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.