🏥 Medical Devices • 6,839 recalls
CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
Expired product was shipped to two customers.
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
Linvatec Corp.
ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Allergen Medical
Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured
The length markings on the Lightspeed LSX files were wrong.
Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45¿ product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.