Kentucky recalls

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.

Olympus is recalling the Thunderbeat 5 mm, 35 cm inline grip surgical instrument (Model TB-0535IC) due to ongoing reports of adverse events during use. This medical device is used in surgical procedures and distributed worldwide.

Olympus Corporation is removing Thunderbeat 5 mm, 45 cm Inline Grip surgical instruments (Model TB-0545IC) due to continued reports of adverse events during use. The recall affects 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.

Olympus Corporation is removing Thunderbeat 5mm pistol grip surgical instruments (Model TB-0535PC) from the market worldwide due to ongoing reports of adverse events during use. No specific injuries have been reported, but the company is taking action out of caution.

Olympus Corporation is removing Olympus Thunderbeat 5 mm, 45 cm pistol grip surgical instruments (Model TB-0545PC) from the market due to ongoing reports of adverse events during use. This Class II recall affects approximately 30 units distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.

Olympus Corporation is recalling the Thunderbeat 5 mm, 20 cm front-actuated grip surgical instrument due to continued reports of adverse events during use. The recall affects all lots of this model worldwide, including the US and several other countries.

Olympus is removing the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip surgical instrument (Model TB-0535FC) from distribution due to ongoing reports of adverse events during use. The device has been distributed worldwide, including across the US and several other countries.

Olympus is recalling the Thunderbeat 5 mm, 45 cm Front-Actuated Grip surgical instrument (Model TB-0545FC) worldwide due to continued reports of adverse events during use. The company has determined that removal of this device from the market is necessary.

Olympus Corporation is removing Thunderbeat 5 mm, 20 cm surgical instruments (Model TB-0520FCS) from the market due to ongoing reports of adverse events during use. The company has identified a safety concern affecting all lots of this device.

Olympus is recalling its Thunderbeat 5 mm, 35 cm Front-Actuated Grip Type S surgical instruments (Model TB-0535FCS) due to ongoing reports of adverse events. The recall affects 88,268 units distributed worldwide, including in the United States, Brazil, Canada, Germany, Mexico, and Japan.

Olympus Corporation is removing the Thunderbeat 5 mm, 45 cm Front-Actuated Grip Type S surgical instrument from use worldwide due to ongoing reports of adverse events during use. This affects approximately 9,542 units across the US and several other countries.

Medica Corporation's capillary tubes used with EasyBloodGas and EasyStat devices are giving false potassium results—up to 20% higher than actual levels. This could lead doctors to misinterpret a patient's potassium levels and provide incorrect treatment.