MedWatch Safety Alerts RSS Feed http://www.fda.gov/ en Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment http://www.fda.gov/medical-devices/medical-device-recalls/baxter-hillrom-recalls-watchcare-incontinence-management-system-ims-risk-rf-interference-nearby The WatchCare IMS includes hospital beds and disposable incontinence pads. Radiofrequency emissions from the system may interfere with other medical devices. Wed, 23 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/baxter-hillrom-recalls-watchcare-incontinence-management-system-ims-risk-rf-interference-nearby 2022 Medical Device Recalls http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Wed, 23 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis http://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Tue, 22 Nov 2022 18:41:00 EST FDA http://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls 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 Tue, 22 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/faqs-philips-respironics-ventilator-bipap-machine-and-cpap-machine-recalls Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication 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. Tue, 22 Nov 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 2022 Safety Communications http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Fri, 18 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms. Thu, 17 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety Insulet Recalls Omnipod DASH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or Extreme Overheating http://www.fda.gov/medical-devices/medical-device-recalls/insulet-recalls-omnipod-dash-insulin-management-systems-personal-diabetes-manager-pdm-risk-battery Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating. Wed, 16 Nov 2022 15:35:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/insulet-recalls-omnipod-dash-insulin-management-systems-personal-diabetes-manager-pdm-risk-battery Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. This does not impact the Omnipod 5 Pod, the Omnipod® DASH Insulin M Tue, 15 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issues-nationwide-voluntary-medical-device-correction-omnipodr-5-controller Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA http://www.fda.gov/medical-devices/safety-communications/exactitud-y-limitaciones-de-los-pulsioximetros-comunicado-de-seguridad-de-la-fda La FDA está informando a los pacientes y proveedores de atención médica de que los oxímetros de pulso tienen limitaciones y un riesgo de inexactitud que debe tenerse en cuenta. Mon, 07 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/exactitud-y-limitaciones-de-los-pulsioximetros-comunicado-de-seguridad-de-la-fda Pulse Oximeter Accuracy and Limitations: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered. Mon, 07 Nov 2022 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adams-polishes-llc-issues-voluntary-nationwide-recall-hand-sanitizer-due-potential-contamination Thornton, Colorado, Adam’s Polishes, LLC is voluntarily recalling lot 133475 of Adam’s Polishes Hand Sanitizer to the consumer level. FDA testing has found this lot to contain undeclared methanol. Adam’s Polishes is recalling 19 other lots in an abundance of caution. Persons who accidently ingest ( Mon, 07 Nov 2022 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adams-polishes-llc-issues-voluntary-nationwide-recall-hand-sanitizer-due-potential-contamination Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issued-voluntary-medical-device-correction-omnipod-dashr-personal-diabetes-manager-october Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH® Personal Diabetes Managers (PDMs) distributed globally. This action was taken voluntarily with the knowledge of the FDA and other regulatory agencies. Sat, 05 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-issued-voluntary-medical-device-correction-omnipod-dashr-personal-diabetes-manager-october Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teleflex-announces-worldwide-recall-gibeckr-iso-gardr-filter Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced Gibeck® Iso-Gard® Filter products. The Gibeck® Iso-Gard® Filter is a bacterial and viral filter, intended for Fri, 04 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teleflex-announces-worldwide-recall-gibeckr-iso-gardr-filter Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/do-not-use-infant-head-shaping-pillows-prevent-or-treat-any-medical-condition-fda-safety The FDA recommends that parents, caregivers, and health care providers not to use infant head shaping pillows to prevent or treat any medical condition. Thu, 03 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-infant-head-shaping-pillows-prevent-or-treat-any-medical-condition-fda-safety Teleflex Recalls Iso-Gard Filter S for Risk of Splitting or Detaching That May Cause Leakage and Insufficient Air Supply to Patients http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-recalls-iso-gard-filter-s-risk-splitting-or-detaching-may-cause-leakage-and-insufficient The Iso-Gard Filter S is a breathing circuit bacterial filter. It may split or detach preventing patients from getting sufficient supply of air. Wed, 02 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-recalls-iso-gard-filter-s-risk-splitting-or-detaching-may-cause-leakage-and-insufficient 2022 Letters to Health Care Providers http://www.fda.gov/medical-devices/letters-health-care-providers/2022-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Tue, 01 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2022-letters-health-care-providers Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers http://www.fda.gov/medical-devices/letters-health-care-providers/consider-alternatives-mri-guided-breast-biopsy-grid-plates-due-shortage-letter-health-care-providers The FDA recommends health care providers discuss alternatives for MRI-guided breast biopsies with patients due to shortage of Philips Invivo plates and disposables. Mon, 31 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/consider-alternatives-mri-guided-breast-biopsy-grid-plates-due-shortage-letter-health-care-providers Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/reuse-tracheostomy-tubes-or-switch-appropriate-alternatives-during-shortage-fda-safety-communication The FDA recommends using the following strategies to reduce the number of tracheostomy tubes used per patient during the shortage. Mon, 31 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/reuse-tracheostomy-tubes-or-switch-appropriate-alternatives-during-shortage-fda-safety-communication Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers http://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines Fri, 28 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured