Medical device recalls

Olympus has recalled a urologic resection sheath (Model A22040T) because the ceramic tip can break during use. The FDA has classified this as a Class II recall, meaning the defect could cause serious harm. No injuries have been reported so far.

Olympus has recalled a urologic resection sheath (Model A22040A) because the ceramic tip can break during use. The FDA has classified this as a Class II recall affecting 6,949 units distributed nationwide. No injuries have been reported.

The ceramic tip on Olympus Resection Sheath models A22014A and A22014T can break during use. These devices are used by doctors during urological procedures. The company has received complaints about this issue affecting 29 units nationwide.

Olympus is recalling the Cystoscope Outer Sheath model WA22810A because it is incompatible with GreenLight Laser systems used for prostate (BPH) treatment. Using this sheath with the laser can damage the tip of the device, potentially affecting the safety and function of the cystoscope.

MRIMed's SL-111 battery for the Mobile Exam Light (model SL-110) can overheat while charging, causing internal components to melt and create smoke. This affects 314 batteries with specific lot numbers distributed nationwide and internationally.

Meijer sterile saline wound wash (0.9% sodium chloride, 7.1 fl oz) may not have been manufactured to meet required sterility standards. The manufacturer did not follow proper sterilization procedures for this wound-cleaning product. All lots of model MJSALINE7 are affected.

Medline has recalled specific lots of its Nail Kit (Model DYKM1528) because the sterile saline wound wash included in the kit may not meet required sterility standards. The saline solution could potentially be contaminated. No injuries have been reported so far.

Medline recalled five models of Convenience Kits because the sterile saline wound wash component may not meet required sterility safety standards. The affected kits were distributed for medical use. No injuries have been reported.

Medline is recalling specific lots of its Convenience Nail Kit because the sterile saline wound wash component may not meet required sterility standards. The affected product was distributed nationwide and to several Caribbean locations. No injuries have been reported.

Medline Industries recalled its 7.1 FL OZ Sterile Saline Wound Wash because the manufacturer may not have properly sterilized the product to meet safety standards. This affects all lots of model MDSALINE7 distributed nationwide and in the Caribbean. No injuries have been reported.

Hitachi's Proton Beam Therapy system (model PROBEAT-CR) has a software issue that may cause the patient positioning system to be inaccurate during treatment. One unit was distributed in Texas and Washington, DC. No injuries have been reported.

Hitachi's Proton Beam Therapy System (model PROBEAT-FR) has a software issue that could cause the patient positioning system to place a patient slightly out of the intended treatment position. This affects one system installed in the US. No injuries have been reported.

A software update (version P1.2.1) for the Intuitive Surgical Da Vinci 5 surgical system can cause the user interface to disappear from external or tower monitors during use. This affects 12 systems distributed in six U.S. states. No injuries have been reported.

Stryker is recalling certain MOLLI 2 surgical marker systems because the instructions for use need to be updated. Magnetized surgical tools used during the procedure may dislodge the markers that are placed to mark the surgical site. Stryker is providing updated labeling to address this issue.

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.