http://www.fda.gov/ en http://www.fda.gov/medical-devices/letters-health-care-providers/hsv-2-tests-genital-herpes-can-produce-false-reactive-results-letter-clinical-laboratory-staff-and Herpes simplex virus-2 serological tests can produce false reactive results especially if a person has a low risk of infection or if test results are near the test’s cut-off. Wed, 27 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/letters-health-care-providers/hsv-2-tests-genital-herpes-can-produce-false-reactive-results-letter-clinical-laboratory-staff-and 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. Wed, 27 Dec 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/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-84-sodium-bicarbonate Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP ABBOJECT® Glass Syringe, 5 mEq/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield® ABBOJECT® Glass Syringe, 50 mEq/50 mL; and Atropine Sulfate Injection, USP L Tue, 26 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-42-sodium-bicarbonate-injection-84-sodium-bicarbonate http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bleomycin-injection-usp-15-units-single-dose Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single via Fri, 22 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bleomycin-injection-usp-15-units-single-dose http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-americainer-20-benzocaine-topical Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a r Fri, 22 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insight-pharmaceuticals-issues-voluntary-nationwide-recall-americainer-20-benzocaine-topical http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resmed-notifies-customers-about-updated-instructions-and-labeling-masks-magnets-due-potential ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require a Thu, 21 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resmed-notifies-customers-about-updated-instructions-and-labeling-masks-magnets-due-potential http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based On November 21, 2023, Busse Hospital Disposals ini􀆟ated a na􀆟onwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse ini􀆟ated this recall in direct response to Nurse Assi Wed, 20 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Wed, 20 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-voluntary-nationwide-recall-various-lots-tracheostomy-care-and-cleaning Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture tubing Wed, 20 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-voluntary-nationwide-recall-various-lots-tracheostomy-care-and-cleaning http://www.fda.gov/medical-devices/medical-device-recalls/philips-north-america-llc-recalls-panorama-10t-hfo-due-risk-explosion-during-quench-procedure-caused Philips Panorama 1.0T HFO is being recalled due to a risk of explosion during a quench procedure caused by too much helium gas building up. Wed, 20 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/philips-north-america-llc-recalls-panorama-10t-hfo-due-risk-explosion-during-quench-procedure-caused http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-navigation-inc-recalls-stealthstation-s8-application-version-20-and-201-due-software Medtronic Navigation Inc. is recalling StealthStation S8 Application Version 2.0 and 2.0.1 due to a software glitch that can make surgical data shift locations. Tue, 19 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-navigation-inc-recalls-stealthstation-s8-application-version-20-and-201-due-software http://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety Nurse Assist, LLC announced a recall because the products may not be sterile. Patients are at risk of infection. Tue, 19 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety http://www.fda.gov/medical-devices/medical-device-recalls/olympus-corporation-americas-recalls-bronchofiberscopes-and-bronchovideoscopes-because-they-can-lead Olympus bronchoscopes, used to examine or treat a person's airways, are being recalled because they can lead to burns and fire. Tue, 19 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/olympus-corporation-americas-recalls-bronchofiberscopes-and-bronchovideoscopes-because-they-can-lead http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Tue, 19 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications 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. Tue, 19 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/safety/recalls-market-withdrawals-safety-alerts/invagen-pharmaceuticals-issues-voluntary-nationwide-recall-vigabatrin-oral-solution-usp-500mg-due Hauppauge, NY, Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowi Mon, 18 Dec 2023 10:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/invagen-pharmaceuticals-issues-voluntary-nationwide-recall-vigabatrin-oral-solution-usp-500mg-due http://www.fda.gov/medical-devices/medical-device-recalls/getinge-recalls-cardiohelp-emergency-drive-due-impaired-or-inability-turn-drive Getinge is recalling the CARDIOHELP Emergency Drive because it can become stuck or difficult to turn due to friction being generated in the handle attachment. Fri, 08 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/getinge-recalls-cardiohelp-emergency-drive-due-impaired-or-inability-turn-drive 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. Thu, 07 Dec 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/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urolo Thu, 07 Dec 2023 00:00:00 EST FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-issues-medical-device-recall-nurse-assist-products-contained-within-kitstrays http://www.fda.gov/medical-devices/medical-device-recalls/cordis-us-corp-recalls-infiniti-angiographic-catheter-due-products-being-shipped-without-undergoing The Cordis INFINITI Angiographic Catheter is being recalled due to some of the products being shipped to end users without undergoing sterilization procedures. Tue, 05 Dec 2023 00:00:00 EST FDA http://www.fda.gov/medical-devices/medical-device-recalls/cordis-us-corp-recalls-infiniti-angiographic-catheter-due-products-being-shipped-without-undergoing