http://www.fda.gov/ en http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white par Thu, 28 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res Wed, 27 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Tue, 26 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls 2024 Medical Device Recalls Mon, 25 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls http://www.fda.gov/medical-devices/medical-device-recalls/medline-industries-recalls-certain-kits-and-trays-containing-sterile-water-based-products-under Medline Industries recalls kits and trays due to sterility concerns linked to Nurse Assist's November 6, 2023, recall. Mon, 25 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medline-industries-recalls-certain-kits-and-trays-containing-sterile-water-based-products-under http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-airlife-manual-resuscitators-due-manufacturing-defect-can-lead-injury-or Vyaire recalls AirLife manual resuscitators because a manufacturing defect could result in patients not receiving enough ventilation, leading to injury or death. Thu, 21 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-airlife-manual-resuscitators-due-manufacturing-defect-can-lead-injury-or http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks The Impella device's catheter could cut through the wall of the left ventricle. Thu, 21 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). Wed, 20 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-removal-announcement-infutronix-nimbus-ambulatory-infusion-pump-system InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump sys Wed, 20 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-removal-announcement-infutronix-nimbus-ambulatory-infusion-pump-system http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications Listing of Medical Device 2024 Safety Communications Tue, 19 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Mon, 18 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with t Mon, 18 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference http://www.fda.gov/medical-devices/medical-device-recalls/avanos-recalls-mic-gastric-jejunal-feeding-tube-kits-containing-sterile-water-based-products-under Avanos Recalls Kits Containing Nurse Assist Saline Thu, 14 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/avanos-recalls-mic-gastric-jejunal-feeding-tube-kits-containing-sterile-water-based-products-under http://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection. Tue, 12 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot-treprostinil-injection-due-potential Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulate Tue, 12 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot-treprostinil-injection-due-potential http://www.fda.gov/medical-devices/medical-device-recalls/windstone-medical-packaging-inc-recalls-local-lower-extremity-pack-house-ocular-pack-and-closure-kit Windstone Medical Packaging recalls kits (Lower Extremity, Ocular, Closure) due to sterility concerns linked to Nurse Assist's November 6, 2023, recall. Mon, 11 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/windstone-medical-packaging-inc-recalls-local-lower-extremity-pack-house-ocular-pack-and-closure-kit http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-heartmate-touch-communication-system-unintentional-pump-start-and-stop The Abbott HeartMate Touch Communication System is being recalled due to the risk of unintended communication with the HeartMate System Controller resulting in pump stop of the HeartMate 3 Left Ventricular Assist Device. Mon, 11 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-heartmate-touch-communication-system-unintentional-pump-start-and-stop http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-cardinal-health-monoject-luer-lock-and-enteral-syringes-fda-safety-communication The FDA is warning not to use recalled Cardinal Health Monoject syringes, including Luer-Lock and enteral. Thu, 07 Mar 2024 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-cardinal-health-monoject-luer-lock-and-enteral-syringes-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Thu, 07 Mar 2024 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-neurosurgery-recalls-duet-external-drainage-and-monitoring-system-catheter-tubing-due Medtronic Neurosurgery is recalling Duet EDMS catheter tubing due to a potential for disconnection from the patient line stopcock connectors. Thu, 07 Mar 2024 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-neurosurgery-recalls-duet-external-drainage-and-monitoring-system-catheter-tubing-due