Medical device recalls

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.

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.

The MONARCH Platform bronchoscopy device has a software issue that can cause the robotic arm to move unexpectedly. If the application restarts after you select a position but before loading the bronchoscope, the system may reset to the left side even if you selected right, potentially causing the arm to contact the patient or breathing tube.

Olympus Corporation is recalling the Thunderbeat 5 mm, 10 cm surgical instrument (Model TB-0510IC) worldwide due to continued reports of adverse events during use. The company has decided to remove all 1,538 units from distribution.

Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments from the market due to ongoing reports of adverse events during use. About 140 units with model number TB-0520IC have been distributed worldwide, including across the US and in Brazil, Canada, Germany, Mexico, and Japan.