Medical device recalls

Medline kits containing Olympus biopsy valves may have rubber fragments that can detach inside the valve. These fragments could enter a patient's airway and require removal, or cause inflammation and breathing problems. Olympus is investigating complaints about this issue.

Medline's thoracic robot kits contain Olympus biopsy valves that may shed rubber fragments during use. These fragments could lodge in a patient's airway, potentially requiring removal and causing breathing problems or inflammation.

Medline convenience kits containing Olympus biopsy valves may have defective valves that shed rubber fragments during use. These fragments could lodge in a patient's airway, potentially requiring removal and causing inflammation or breathing problems.

Medline's Airway Exam Kit contains Olympus biopsy valves that may shed rubber fragments. These fragments can lodge in a patient's airway and may require removal. This could cause inflammation, low oxygen levels, or extend the procedure time.

Summa Therapeutics is recalling certain Finesse BTK Multicath injectable angioplasty balloon catheters because the balloon may not meet burst strength specifications. This could cause the balloon to rupture unexpectedly during a medical procedure. The recall affects 22 units distributed in New Jersey and Florida.

Synthes shipped Cortical Screw Tap lot 68982P8 that was accidentally swapped with a different product lot during manufacturing. The affected screws have an incorrect thread that could cause them to fail during orthopedic surgery. The error affected 33 units distributed across multiple states.

Synthes shipped VOLT Locking Screw Taps with the wrong internal thread design due to a packaging error during manufacturing. The affected lot (68900P9) contains 77 units distributed across 21 U.S. states. Using the wrong tap could result in improper screw placement during orthopedic surgery.

Intuitive Surgical is recalling certain da Vinci S and Si reusable cautery hook surgical instruments (model 420183) because the internal pitch cables that control the instrument tip can fray or break during use. This could affect the surgeon's ability to control the instrument during a procedure. No injuries have been reported.

Intuitive Surgical is recalling certain da Vinci S and Si Tenaculum Forceps instruments (Model 420207) because the internal pitch cables that control the instrument tip can fray or break during use. This could affect the surgeon's ability to control the instrument properly during a procedure. No injuries have been reported so far.

Intuitive Surgical has recalled certain da Vinci S and Si Grasping Retractor instruments (Model 420278) due to reports of broken or frayed grip cables. The cables transmit motion from the surgeon's controls to the instrument tip during minimally invasive surgery. A cable failure could affect the surgeon's ability to control the instrument during a procedure.

Intuitive Surgical has recalled certain da Vinci S and Si Mega Needle Driver surgical instruments due to complaints of broken or frayed grip cables. These cables transmit motion from the surgeon's controls to the instrument tip inside the patient. The issue affects specific batch numbers manufactured between 2010 and 2018.

Intuitive Surgical has recalled certain da Vinci S and Si Double Fenestrated Grasper reusable surgical instruments due to reports of broken or frayed grip cables. The cables transmit motion from the surgeon's input to the instrument tip inside the patient. A cable failure during surgery could compromise the surgeon's ability to control the instrument.

Intuitive Surgical is recalling specific batches of da Vinci S and Si Monopolar Curved Scissors (model 420179) used in robotic surgery systems. The grip cables inside these instruments can break or fray during use, which could affect the surgeon's ability to control the instrument during a procedure.

Olympus identified a defect in the 24V power supply module in some SOLTIVE Pro laser systems that may cause the device to stop working. In some cases, smoke or a burning smell may occur inside the laser console, though the design contains any smoke within the enclosure where it will self-extinguish.

Olympus identified a defect in the 24V power supply module in some SOLTIVE Premium laser systems that may cause the device to stop working. In some cases, smoke or a burning smell may occur inside the laser console, though the design contains any smoke within the internal enclosure where it will self-extinguish.

Medline Industries identified a potential breach in the sterile pouch packaging of one lot of Sterile Radiology Procedure Kits (Model DYNDH1491B). This breach may allow the kit to lose its sterile condition. No injuries have been reported.

Philips Vue Motion V12 cardiac imaging software (Product Number 1017979, software versions 12.2.0 through 12.2.8.500) may display image frames out of sequence during dynamic cine runs. This could cause medical staff to review cardiac images in the wrong order, potentially affecting diagnosis.

Medline Industries recalled two G-tube care kits (SKU DYKM2720 and SKU ENFITDISCKIT) because the connectors were not made to the right size. This means they may not seal properly with ENFit-style feeding tubes, which could cause leakage of nutrition or fluids. If you try to tighten the connector to stop leaking, it could cause injury, infection, or discomfort.

Medline's ENFIT G-tube connectors (Item No. ENFIT1010GC) were not made to the correct specifications and may not seal properly with ENFit-style medical devices. This can cause leakage of feeding fluids and delay necessary care. If users tighten the connector too much to stop the leak, it can cause infection, discomfort, and require additional medical treatment.

Ultradent Products is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk because the cups may crumble or break apart during use. This could delay dental treatment. The affected product has lot number 529983 and expiration date of September 2, 2031.

The surgical light assembly in Stryker CHROMOPHARE Softlit Ring systems may not adequately support the weight of the ceiling cover. This could potentially cause the cover to fall. No injuries have been reported.

Mentor Texas has recalled Artoura Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during the expansion procedure and may cause the needle to break.

The infusion sets included with certain Mentor Artoura Breast Tissue Expanders may have dull or blunt needle tips. This defect can make it difficult to insert the needle during the inflation procedure and may cause the needle to break.

Mentor Texas, LP is recalling Artoura Breast Tissue Expanders because the infusion sets (the needle and delivery mechanism) may have dull or blunt needle tips. This can make it difficult to insert the needle during the expansion procedure or cause the needle to break.

Mentor Texas breast tissue expanders used in reconstruction surgery may have infusion sets with dull or blunt needle tips. These needles may be difficult to insert during the expansion process and could break inside the device. No injuries have been reported.

Mentor Texas has recalled CPX 4 breast tissue expanders because the infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during treatment or cause it to break. No injuries have been reported.

Mentor Texas has recalled CPX 4 US Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. These dull needles can be hard to insert and may break during use. No injuries have been reported.

Mentor Texas is recalling certain CPX 4 breast tissue expanders because the infusion sets may have a dull or blunt needle tip. This can make it difficult to insert the needle or cause it to break during use. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Azurion 5 M20 X-ray imaging systems where the X-ray may not start or may start and stop unexpectedly. This affects 920 systems worldwide, including 168 in the U.S. No injuries have been reported.

Philips has identified a problem with the wired foot switch on certain Azurion 5 M12 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This affects specific system serial numbers distributed worldwide. No injuries have been reported.