MedWatch Safety Alerts RSS Feed http://www.fda.gov/ en Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients http://www.fda.gov/medical-devices/medical-device-recalls/electrode-pad-recall-megadyne-removes-megadyne-mega-soft-pediatric-patient-return-electrodes-risk MEGA SOFT Pediatric Patient Return Electrodes used during monopolar electrosurgery may cause serious burn injuries to patients. Thu, 13 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/electrode-pad-recall-megadyne-removes-megadyne-mega-soft-pediatric-patient-return-electrodes-risk Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm http://www.fda.gov/medical-devices/medical-device-recalls/teleflexarrow-international-recall-arrow-fiberoptix-and-ultraflex-intra-aortic-balloon-iab-catheter Arrow FiberOptix and UltraFlex IAB Catheter Kits provide circulatory support. A manufacturing issue may prevent the balloon from fully inflating. Thu, 13 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/teleflexarrow-international-recall-arrow-fiberoptix-and-ultraflex-intra-aortic-balloon-iab-catheter 2024 Medical Device Recalls http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls 2024 Medical Device Recalls Thu, 13 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride http://www.fda.gov/medical-devices/medical-device-recalls/getinge-recalls-vaporizer-sevoflurane-maquet-filling-risk-patient-and-health-care-professional Vaporizer Sevoflurane Maquet Filling is part of the Flow anesthesia systems but may expose patients or health professionals to toxic hydrogen fluoride. Thu, 13 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/getinge-recalls-vaporizer-sevoflurane-maquet-filling-risk-patient-and-health-care-professional Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/suntegrity-skincare-issues-voluntary-recall-suntegrity-impeccable-skin-sunscreen-foundation-multiple Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 1 Wed, 12 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/suntegrity-skincare-issues-voluntary-recall-suntegrity-impeccable-skin-sunscreen-foundation-multiple UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Tue, 11 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication Male Enhancement Supplements Recalled http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/male-enhancement-supplements-recalled Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment o Tue, 11 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/male-enhancement-supplements-recalled Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-medline-industries-lp-removes-medline-sub-g-endotracheal-tube-subglottic Medline Industries, LP is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other components from the main tube. Tue, 11 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-medline-industries-lp-removes-medline-sub-g-endotracheal-tube-subglottic 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. Mon, 10 Jun 2024 15:54:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/insulet-recalls-omnipod-dash-insulin-management-systems-personal-diabetes-manager-pdm-risk-battery UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers http://www.fda.gov/medical-devices/letters-health-care-providers/update-change-reprocessing-methods-certain-karl-storz-urological-endoscopes-letter-health-care Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz. Thu, 06 Jun 2024 16:12:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-change-reprocessing-methods-certain-karl-storz-urological-endoscopes-letter-health-care Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-stealthstation-s8-application-versions-120-110-103-102-and-101-software-error-may The software error may cause numbers or letters to be missing from the displayed text and may result in the mechanical depth stop being set too short or too long. Wed, 05 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-stealthstation-s8-application-versions-120-110-103-102-and-101-software-error-may HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homeocare-laboratories-inc-issues-voluntary-nationwide-recall-homeopathic-stella-life-oral-care HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level. Wed, 05 Jun 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homeocare-laboratories-inc-issues-voluntary-nationwide-recall-homeopathic-stella-life-oral-care Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-subg-endotracheal-tube-subglottic-suction On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, l Fri, 31 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-subg-endotracheal-tube-subglottic-suction OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC http://www.fda.gov/medical-devices/medical-device-recalls/optumhealth-care-solutions-recalls-nimbus-ii-infusion-pump-systems-under-recall-infutronix-llc Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death. Thu, 30 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/optumhealth-care-solutions-recalls-nimbus-ii-infusion-pump-systems-under-recall-infutronix-llc Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injec Wed, 29 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-docetaxel-injection-usp-due-potential Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-twin-tube-due-potential-nozzle-separating-during-patient-use Vyaire Medical recalls Twin Tube due to potential nozzle separation risk posing a choking hazard. Thu, 23 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-twin-tube-due-potential-nozzle-separating-during-patient-use Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices http://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices. Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication http://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others. Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/biozorb-markers-and-potential-risks-use-breast-tissue-fda-safety-communication Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incompl Wed, 22 May 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-buprenorphine-hydrochloride-injection-carpujecttm BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations http://www.fda.gov/medical-devices/medical-device-recalls/biomerieux-inc-recalls-vitek-2-ast-kit-due-incorrect-ceftriaxone-concentrations BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells. Wed, 15 May 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/biomerieux-inc-recalls-vitek-2-ast-kit-due-incorrect-ceftriaxone-concentrations