689 recalls tagged with “fda regulated”.
Cardinal Health distributed LEADER Ultra Lubricating Eye Drops and related store-brand lubricating eye drops nationwide. The recall cites a lack of assurance of sterility. Consumers should stop using these products immediately and contact KC Pharmaceuticals for guidance.
Leader Artificial Tears Sterile Lubricant Eye Drops sold nationwide are recalled due to lack of assurance of sterility. The recall involves multiple store-brand lines distributed by Cardinal Health and others. Consumers should stop using the product immediately and follow recall guidance from KC Pharmaceuticals via email.
Philips Medical Systems Nederland B.V. recalls 296 Allura Xper FD20/15 imaging systems distributed nationwide and internationally after reports the wired foot switch may fail to initiate imaging or start intermittently. The defect can delay X-ray imaging in patient care. Healthcare providers and patients should stop using the device and follow recall instructions from the manufacturer.
Philips Medical Systems Nederland B.V. recalled 5 Allura Xper FD20/20 OR Tables distributed nationwide and internationally after detecting intermittent X-ray activation with the wired foot switch. The defect can prevent X-ray imaging from starting or cause it to stop during procedures. Hospitals and clinicians should stop using the affected tables and await manufacturer guidance.
Philips Medical Systems Nederland B.V. recalled 15 Allura Xper FD10C radiography systems worldwide, including 7 in the United States and 8 overseas. The devices may fail to initiate X-ray imaging or intermittently stop imaging when using the wired foot switch. Facilities should stop using the devices and await recall instructions from Philips.
Philips Medical Systems Nederland B.V. recalls 10 Allura Xper FD10F imaging systems sold to hospitals worldwide. The devices may fail to start X-ray imaging or start intermittently when using the wired foot switch. Hospitals should stop using the devices immediately and contact Philips for instructions.
Philips Medical Systems Nederland B.V. recalled 196 ALLURA Xper FD20 OR Tables sold to hospitals nationwide and internationally. The defect may prevent X-ray imaging from starting or cause intermittent operation when using the wired foot switch. Hospitals should stop using the devices and follow the recall instructions sent by letter.
Philips is recalling 798 Azurion 3 M15 systems worldwide, including 42 units in the United States. The wired foot switch may fail to initiate X-ray imaging or fail to produce consistent imaging. Healthcare providers should stop using the affected devices and follow recall instructions issued by Philips.
Philips recalled 1,994 Azurion 7 M12 interventional X-ray systems, including 360 units in the United States, for a wiring-foot switch defect that may fail to initiate imaging. The issue can cause imaging to not start or operate intermittently. Hospitals and clinicians should stop using affected devices immediately and follow the manufacturer’s recall instructions.
Philips recalls 670 Azurion 7 B12 X-ray imaging systems after finding the wired foot switch may fail to start imaging. The issue affects 106 US units and 564 in other countries. Hospitals should stop using the device and await manufacturer guidance.
Rising Pharmaceuticals recalls 1,200 Temozolomide 5 mg capsules nationwide after a stability test found out-of-spec impurities. The drug is Rx-only, with NDC 16571-816-51 and lot 1TM0524003A. Stop using immediately and contact a healthcare provider for guidance.
Civco Medical Instruments recalled 10 eTRAX Needle Sensor 16G units for Aurora Trackers. An inspection and programming error could cause the needle tip position to be misidentified on the user interface. Stop using the device immediately and contact Civco for instructions.
Civco Medical Instruments Co. is recalling 5 eTRAX Needle Sensor 14G units for Aurora Trackers. The recall cites a programming and inspection error that could cause the needle tip position to be misidentified on the user interface. Stop using the device immediately and contact Civco for instructions.
Civco Medical Instruments recalled 18 units of the eTRAX Needle System Starter Kit 16G for Aurora Trackers after an inspection and programming error could cause the needle tip position to be misidentified on the user interface. The defect could lead to incorrect needle guidance during a procedure. Healthcare providers and patients should stop using the device immediately and follow the recall ins
Philips Respironics recalled 113,717 Trilogy Evo ventilators worldwide on March 2, 2026. The recall concerns software Version 1.05.15.00 and the use of non-pneumatic nebulizers with the Trilogy Evo platform. Hospitals and patients should stop using the device immediately and follow recall instructions from Philips Respironics or their healthcare provider.
Philips Respironics recalled 113,717 Trilogy Evo Universal ventilators worldwide on March 2, 2026. The recall cites a condition where using non-pneumatic nebulizers may cause a discrepancy between the set tidal volume and the delivered tidal volume. Patients and caregivers should stop using the device immediately and contact Philips Respironics or their healthcare provider for instructions.
Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold worldwide through healthcare distributors on March 2, 2026. Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may cause a mismatch between the set tidal volume and the delivered tidal volume. Patients and healthcare providers should stop using the device immediately and follow the recall instructions from the 제조
Philips Respironics recalled 113,717 Trilogy Evo home-use ventilators worldwide after finding the Obstruction Alarm may fail to trigger, potentially delaying alerts by up to four breaths. The devices were distributed nationwide in the United States and internationally. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions.
Philips Respironics recalled 113,717 Trilogy EV300 ventilators sold in the United States and internationally after determining the Obstruction Alarm may fail to trigger within required standards. The alarm can delay alerting caregivers for up to four breaths. Patients and healthcare providers should stop using the device immediately and follow recall instructions from Philips or their clinician.
Civco Medical Instruments recalled 2 eTRAX Needle System Starter Kit 12G units for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The defect can cause the needle tip position to be incorrectly identified on the user interface. Stop using the device immediately and follow the recall instructions from Civco or your healthcare provider.