http://www.fda.gov/ en http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Flip-top Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial. Tue, 27 Dec 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-vancomycin-hydrochloride-injection-usp http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p Tue, 27 Dec 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gfa-production-xiamen-co-ltd-issues-voluntary-nationwide-recall-easy-care-first-aidr-burn-cream-and http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/accord-healthcare-inc-issues-nationwide-voluntary-recall-daptomycin-injection-500-mgvial-and Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level. Tue, 27 Dec 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/accord-healthcare-inc-issues-nationwide-voluntary-recall-daptomycin-injection-500-mgvial-and http://www.fda.gov/medical-devices/safety-communications/certain-reworked-philips-respironics-trilogy-100200-ventilators-recalled-due-potential-silicone-foam Certain reworked Trilogy ventilators have two recent issues that may cause blockage or debris in the airpath. Thu, 22 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/certain-reworked-philips-respironics-trilogy-100200-ventilators-recalled-due-potential-silicone-foam http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. Thu, 22 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall Thu, 22 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no rep Wed, 21 Dec 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-four-lots-quinapril-tablets-due http://www.fda.gov/medical-devices/medical-device-recalls/arrow-international-llc-subsidiary-teleflex-inc-recalls-arrow-autocat-2-ac3-intra-aortic-balloon Batteries on the Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps deplete faster than expected, which may cause the pump to stop during patient transport. Tue, 20 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/arrow-international-llc-subsidiary-teleflex-inc-recalls-arrow-autocat-2-ac3-intra-aortic-balloon http://www.fda.gov/medical-devices/medical-device-recalls/whele-llc-recalls-mighty-bliss-electric-heating-pads-due-injury-risks-including-electric-shocks-skin Mighty Bliss electric heating pads are being recalled because they may cause injuries including electric shocks, burns, rashes and irritation. Tue, 20 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/whele-llc-recalls-mighty-bliss-electric-heating-pads-due-injury-risks-including-electric-shocks-skin http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Mon, 19 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-llc-recall-arrow-mac-two-lumen-central-venous-access-and-pressure An inadequate connection between housings in Arrow multi-lumen central venous access and catheter kits may cause a cross lumen leak that can harm patients. Fri, 16 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-llc-recall-arrow-mac-two-lumen-central-venous-access-and-pressure http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 thro Mon, 12 Dec 2022 14:31:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots http://www.fda.gov/medical-devices/letters-health-care-providers/2020-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Mon, 12 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2020-letters-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/remel-inc-recalls-thermo-scientific-gram-negative-ivd-ast-sensititre-plate-risk-potential-false Thermo Scientific Gram Negative IVD AST Sensititre Plate is being recalled for a risk of potential false susceptible results when tested with certain antibiotics. Fri, 09 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/remel-inc-recalls-thermo-scientific-gram-negative-ivd-ast-sensititre-plate-risk-potential-false http://www.fda.gov/medical-devices/medical-device-recalls/dewei-medical-equipment-co-recalls-dnarna-preservation-kits-are-not-authorized-cleared-or-approved Dewei Medical Equipment is recalling DNA/RNA Preservation Kits because they were distributed to U.S. customers without FDA authorization, clearance, or approval. Thu, 08 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/dewei-medical-equipment-co-recalls-dnarna-preservation-kits-are-not-authorized-cleared-or-approved http://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms. Tue, 06 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety http://www.fda.gov/medical-devices/safety-communications/actualizacion-de-los-sistemas-endovasculares-de-injerto-de-aaa-endologix-afx-y-el-riesgo-de-endofuga La nueva etiqueta del sistema endovascular AFX2 para AAA (AFX2) incluye información para informar mejor a los pacientes y a los profesionales de la salud sobre el riesgo de endofugas de tipo III. Tue, 06 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/actualizacion-de-los-sistemas-endovasculares-de-injerto-de-aaa-endologix-afx-y-el-riesgo-de-endofuga http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Tue, 06 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-bipap-machines-plastic-issue-may-expose-patients-certain Certain Philips Respironics BiPAP machines are recalled due to a plastic issue that may expose patients to certain chemicals of concern. Tue, 06 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-bipap-machines-plastic-issue-may-expose-patients-certain http://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-bipap-machines-recalled-due-plastic-issue-fda-safety-communication Philips Respironics recalled certain BiPAP machines due to a plastic issue that may release certain chemicals of concern and cause device failure. Tue, 06 Dec 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-bipap-machines-recalled-due-plastic-issue-fda-safety-communication