http://www.fda.gov/ en http://www.fda.gov/medical-devices/medical-device-recalls/eitan-medical-ltd-recalls-sapphire-infusion-pumps-failure-detect-air-line Sapphire Infusion Pumps are being recalled because they may fail to detect air in the line. The failure could cause injury or death. Fri, 01 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/eitan-medical-ltd-recalls-sapphire-infusion-pumps-failure-detect-air-line http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Fri, 01 Dec 2023 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/becton-dickinson-bdcarefusion-303-recalls-alaris-infusion-pumps-due-compatibility-issues-cardinal BD/Carefusion 303 is recalling their Alaris Infusion Pumps to make a correction on compatibility issues with Cardinal Health Monoject syringes. Fri, 01 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bdcarefusion-303-recalls-alaris-infusion-pumps-due-compatibility-issues-cardinal http://www.fda.gov/medical-devices/safety-communications/evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication Consider using plastic syringes not manufactured in China, if possible. Thu, 30 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Thu, 30 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-novum-iq-syringe-infusion-pump-due-potential-impact Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and i Thu, 30 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-novum-iq-syringe-infusion-pump-due-potential-impact http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared E. Hampton NY- Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products f Wed, 29 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared http://www.fda.gov/medical-devices/letters-health-care-providers/left-atrial-appendage-occlusion-laao-devices-potentially-associated-procedural-outcome-differences Recommendations for health care providers due to potential procedural outcome differences between women and men undergoing procedures with LAAO devices. Wed, 29 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/left-atrial-appendage-occlusion-laao-devices-potentially-associated-procedural-outcome-differences http://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication Reports of smoke, sparks, fire, and burns stemming from use of the DreamStation2 CPAP machines prompt warning from the FDA. Tue, 28 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication http://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Tue, 28 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/medical-product-safety-information/bcma-directed-or-cd19-directed-autologous-chimeric-antigen-receptor-car-t-cell-immunotherapies-fda http://www.fda.gov/safety/medical-product-safety-information/antiseizure-medicines-keppra-keppra-xr-elepsia-xr-spritam-levetiracetam-and-onfi-sympazan-clobazam The FDA is warning that the antiseizure medicines can cause a rare but serious reaction, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), that can be life-threatening if not diagnosed and treated quickly. Tue, 28 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/medical-product-safety-information/antiseizure-medicines-keppra-keppra-xr-elepsia-xr-spritam-levetiracetam-and-onfi-sympazan-clobazam http://www.fda.gov/medical-devices/medical-device-recalls/unomedical-recalls-varisoft-infusion-sets-due-damage-connector-piece-causing-unexpected Unomedical A/S is recalling their Varisoft infusion set due to the connector detaching more easily than expected, thereby interrupting the delivery of insulin. Mon, 27 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/unomedical-recalls-varisoft-infusion-sets-due-damage-connector-piece-causing-unexpected http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identifi Mon, 27 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-us-nationwide-recall-two-lots-sandimmuner-oral-solution-cyclosporine-oral http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-tingr-2-miconazole-nitrate-athletes-foot Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third- party lab found that samples fr Fri, 24 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-tingr-2-miconazole-nitrate-athletes-foot http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing. Tue, 21 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-issues-voluntary-recall-nationwide-vitrakvir-larotrectinib-oral-solution-20-mgml-due-presence http://www.fda.gov/medical-devices/safety-communications/voluntary-recall-soclean-equipment-intended-use-cpap-devices-and-accessories-fda-safety A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories. Tue, 21 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/voluntary-recall-soclean-equipment-intended-use-cpap-devices-and-accessories-fda-safety http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/noahs-wholesale-llc-issues-voluntary-nationwide-recall-rock-due-presence-undeclared-sildenafil Miami Gardens, Florida, Noah’s Wholesale, LLC is voluntarily recalling one lot of the rock# 03032021,exp:12/2027,1200 mg/capsule, to the consumer level. FDA analysis has found the product to be tainted with Sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found Tue, 21 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/noahs-wholesale-llc-issues-voluntary-nationwide-recall-rock-due-presence-undeclared-sildenafil http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Mon, 20 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers http://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-cardinal-health-monoject-syringes-syringe-pumps-and-pca-pumps Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps. Mon, 20 Nov 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-cardinal-health-monoject-syringes-syringe-pumps-and-pca-pumps http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kinderfarms-llc-voluntarily-recalling-all-kindermed-pain-fever-products-due-acetaminophen – KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products were manufa Fri, 17 Nov 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kinderfarms-llc-voluntarily-recalling-all-kindermed-pain-fever-products-due-acetaminophen