http://www.fda.gov/ en http://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls List of Medical Device recalls in 2022. Wed, 31 Aug 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/intera-oncology-recalls-intera-3000-hepatic-artery-infusion-pump-due-faster-expected-flow-rates-may The Intera 3000 Hepatic Artery Infusion Pump is being recalled after reports that it has a faster than expected flow rate. Tue, 30 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/intera-oncology-recalls-intera-3000-hepatic-artery-infusion-pump-due-faster-expected-flow-rates-may 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. Mon, 29 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-bipap-machines-recalled-due-plastic-issue-fda-safety-communication http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications Listing of Medical Device 2022 Safety Communications Mon, 29 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications http://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-ag-recalls-hamilton-c6-intensive-care-ventilator-due-potential-water-ingress-may If water enters the Hamilton-C6 Intensive Care Ventilator due to a loose status indicator board, it may cause the ventilator to stop providing breathing support. Mon, 29 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/hamilton-medical-ag-recalls-hamilton-c6-intensive-care-ventilator-due-potential-water-ingress-may http://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-no-longer-authorizes-use-non-niosh-approved-or-decontaminated-disposable-respirators The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems. Fri, 26 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-fda-no-longer-authorizes-use-non-niosh-approved-or-decontaminated-disposable-respirators http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-heartware-hvad-system-batteries-electrical-faults-cause-battery-failure An electrical fault may cause the batteries of the HeartWare HVAD System to fail, leading to severe injury or death. <br /> <br /> Thu, 25 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-heartware-hvad-system-batteries-electrical-faults-cause-battery-failure http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-containing-benzyl Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples. Mon, 22 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-propofol-injectable-emulsion-containing-benzyl http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-cobalt-xt-cobalt-and-crome-icds-and-crt-ds-risk-devices-may-issue-short-circuit Cobalt/Crome ICDs and CRT-Ds may deliver reduced-energy electric shocks and short circuit protection (SCP) alerts during high voltage therapy. Fri, 19 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-cobalt-xt-cobalt-and-crome-icds-and-crt-ds-risk-devices-may-issue-short-circuit 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. Thu, 18 Aug 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/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect. Thu, 18 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub http://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-certain-syringes-and-needles-needle-safety-devices-manufactured-haiou-letter-health-care Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure. Wed, 17 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-certain-syringes-and-needles-needle-safety-devices-manufactured-haiou-letter-health-care 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, 16 Aug 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/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, 16 Aug 2022 00:00:00 EDT 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/medical-device-recalls/becton-dickinson-recalls-intraosseous-needle-set-kits-intraosseous-manual-driver-kits-and Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care. Thu, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-recalls-intraosseous-needle-set-kits-intraosseous-manual-driver-kits-and http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication 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, 11 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-fda-safety-communication http://www.fda.gov/medical-devices/medical-device-recalls/haimen-shengbang-laboratory-equipment-co-ltd-recalls-viral-transport-media-containers-are-not Haimen Shengbang is recalling Viral Transport Media Containers because they were distributed to U.S. customers without FDA authorization, clearance, or approval. Tue, 09 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/haimen-shengbang-laboratory-equipment-co-ltd-recalls-viral-transport-media-containers-are-not http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This lot was previously subject to a retai Thu, 04 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry Thu, 04 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient i Wed, 03 Aug 2022 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared