http://www.fda.gov/ en 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 http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Tue, 01 Nov 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls 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. Tue, 01 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 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 http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Mon, 31 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications 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 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 http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N Tue, 25 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-recall-two-2-lots-quinapril-and http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-mighty-bliss-electric-heating-pads-due-risk-injury-fda-safety-communication Do not to use the recalled Mighty Bliss electric heating pads due to the risks of injury, including electric shocks, skin burns, rashes or irritation. Tue, 25 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-mighty-bliss-electric-heating-pads-due-risk-injury-fda-safety-communication http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass pa Tue, 25 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-institutional-llc-viatris-company-issues-voluntary-recall-one-lot-octreotide-acetate-injection http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whele-llc-announces-national-voluntary-recall-mighty-bliss-electric-heating-pad-due-product-safety Boston, MA, October 18, 2022 / PRNewswire / – Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation Mon, 24 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whele-llc-announces-national-voluntary-recall-mighty-bliss-electric-heating-pad-due-product-safety http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-regarding-potential-radio-frequency-interference Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare system is designed to discreetly alert the caregiver of an inc Mon, 24 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-regarding-potential-radio-frequency-interference http://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect Certain Philips masks can cause potential injury or death if magnets interfere with certain implanted metallic medical devices or metallic objects in the body. Wed, 19 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-masks-bipap-cpap-machines-recalled-due-safety-issue-magnets-may-affect http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-masks-bipap-cpap-machines-due-safety-issue-magnets-may-affect Certain Philips Respironics masks for BiPAP and CPAP machines are recalled due to a risk that their magnetic clips may interact with other medical devices. Wed, 19 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-masks-bipap-cpap-machines-due-safety-issue-magnets-may-affect 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 Wed, 19 Oct 2022 00:00:00 EDT 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/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50 Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failur Thu, 13 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-injection-usp-84-50 http://www.fda.gov/medical-devices/medical-device-recalls/jiangsu-well-biotech-co-ltd-recalls-covid-19-ag-rapid-test-devices-are-not-authorized-cleared-or Jiangsu Well Biotech is recalling COVID-19 Ag Rapid Test Devices because they are not authorized, cleared, or approved by the FDA. Wed, 12 Oct 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/jiangsu-well-biotech-co-ltd-recalls-covid-19-ag-rapid-test-devices-are-not-authorized-cleared-or http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-recalls-lifesparc-system-risk-unintentional-extended-pump-stop-during-controller The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction. Fri, 30 Sep 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-recalls-lifesparc-system-risk-unintentional-extended-pump-stop-during-controller http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-atenolol-25-mg-tablets-and Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This Thu, 29 Sep 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-atenolol-25-mg-tablets-and http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/proper-trade-llcmy-stellar-lifestyle-issues-voluntary-nationwide-recall-wonder-pill-capsules-due Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501 Wed, 28 Sep 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/proper-trade-llcmy-stellar-lifestyle-issues-voluntary-nationwide-recall-wonder-pill-capsules-due