MedWatch Safety Alerts RSS Feed http://www.fda.gov/ en 2024 Safety Communications http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications Listing of Medical Device 2024 Safety Communications Thu, 11 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications 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 Wed, 10 Apr 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 Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-convenience-kits-containing-nurse-assist-09-sodium Northfield, Ill., Apr. 5, 2024 – In direct response to the Nurse Assist, LLC voluntary product recall initiated on November 6, 2023, for saline and sterile water medical products, Medline Industries, LP initiated a nationwide recall on November 15, 2023, for its Medline and Centurion branded conveni Mon, 08 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medline-industries-lp-issues-nationwide-recall-convenience-kits-containing-nurse-assist-09-sodium Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station Due to a Lack of Appropriate Policies and Procedures by Honeywell’s Supplier http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/honeywell-safety-products-usa-inc-issues-voluntary-worldwide-recall-honeywell-fendall-2000-non Charlotte, NC, Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has bee Fri, 05 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/honeywell-safety-products-usa-inc-issues-voluntary-worldwide-recall-honeywell-fendall-2000-non Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aruba-aloe-balm-nv-issues-voluntary-nationwide-recall-aruba-aloe-hand-sanitizer-gel-alcohol-80-and Oranjestad, Aruba, Aruba Aloe Balm N.V. is voluntarily recalling 40 lots of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel to the consumer level. The products have been found to contain alcohol denatured with methanol. <br /> Fri, 05 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aruba-aloe-balm-nv-issues-voluntary-nationwide-recall-aruba-aloe-hand-sanitizer-gel-alcohol-80-and 2024 Medical Device Recalls http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls 2024 Medical Device Recalls Thu, 04 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2024-medical-device-recalls Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation http://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-asd-recalls-pneupac-parapac-plus-300-and-310-ventilator-kits-malfunction-causing-non Smiths Medical ParaPAC Plus ventilators are used in transport and emergencies. A malfunction keeps the ventilator from providing necessary breathing support. Thu, 04 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-asd-recalls-pneupac-parapac-plus-300-and-310-ventilator-kits-malfunction-causing-non Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft http://www.fda.gov/medical-devices/medical-device-recalls/medos-international-sarl-recalls-cerenovus-cerebase-da-guide-sheath-due-cracking-distal-catheter Medos International Sarl is recalling Cerenovus CEREBASE DA Guide Sheath due to fractures in the distal catheter shaft where parts are joined. Thu, 04 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medos-international-sarl-recalls-cerenovus-cerebase-da-guide-sheath-due-cracking-distal-catheter Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-recall-arrow-quickflash-radial-artery-and-radial-arteryarterial ARROW QuickFlash Catheterization Kits are being recalled after reports of increased resistance with the guide wire and chamber during use. Wed, 03 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/teleflex-and-arrow-international-recall-arrow-quickflash-radial-artery-and-radial-arteryarterial AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Risk Statement: In the population most at risk, immunocom Mon, 01 Apr 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due Eugia US LLC (f/k/a AuroMedics Pharma LLC) Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) Due to Presence of White Particles http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white par Thu, 28 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res Wed, 27 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution 2023 Safety Communications http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Tue, 26 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist http://www.fda.gov/medical-devices/medical-device-recalls/medline-industries-recalls-certain-kits-and-trays-containing-sterile-water-based-products-under Medline Industries recalls kits and trays due to sterility concerns linked to Nurse Assist&#039;s November 6, 2023, recall. Mon, 25 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medline-industries-recalls-certain-kits-and-trays-containing-sterile-water-based-products-under Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-airlife-manual-resuscitators-due-manufacturing-defect-can-lead-injury-or Vyaire recalls AirLife manual resuscitators because a manufacturing defect could result in patients not receiving enough ventilation, leading to injury or death. Thu, 21 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/vyaire-medical-inc-recalls-airlife-manual-resuscitators-due-manufacturing-defect-can-lead-injury-or Abiomed Recalls the Instructions for Use for Impella Left Sided Blood Pumps due to Perforation Risks http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks The Impella device&#039;s catheter could cut through the wall of the left ventricle. Thu, 21 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-removal-announcement-infutronix-nimbus-ambulatory-infusion-pump-system InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump sys Wed, 20 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-removal-announcement-infutronix-nimbus-ambulatory-infusion-pump-system Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement Because They Contain Undeclared Prescription Drugs Including Sildenafil (Viagra) and/or Tadalafil (Cialis) http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). Wed, 20 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pyramid-wholesale-issues-recall-various-brands-products-sold-dietary-supplements-sexual-enhancement Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with t Mon, 18 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sleepnet-corporation-issues-worldwide-recall-cpap-and-bipap-masks-magnets-due-potential-interference Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist http://www.fda.gov/medical-devices/medical-device-recalls/avanos-recalls-mic-gastric-jejunal-feeding-tube-kits-containing-sterile-water-based-products-under Avanos Recalls Kits Containing Nurse Assist Saline Thu, 14 Mar 2024 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/avanos-recalls-mic-gastric-jejunal-feeding-tube-kits-containing-sterile-water-based-products-under