/ en Thu, 31 Jul 2025 17:58:02 -0500 Thu, 24 Jul 25 16:30:57 -0500 /news/headline/2025-07-24-fda-issues-most-serious-recall-edwards-lifesciences-cannulas <p>The Food and Drug Administration has identified a <a href="https://www.fda.gov/medical-devices/medical-device-recalls/arterial-cannula-recall-edwards-lifesciences-removes-arterial-cannula-due-risk-wire-exposure">Class I recall</a> of Edwards Lifesciences OptiSite Arterial Perfusion Cannula devices due to the potential for serious injury or death. Edwards identified incidents in which a 3mm to 4mm section of wire from the wire-reinforcement coil at the cannula tip was found to be exposed. The FDA said that some Femoral Arterial Cannula models are made of the same components as the OptiSite Arterial Perfusion Cannula models. Edwards has called for both products to be removed from wherever they are used or sold.</p> Thu, 24 Jul 2025 16:30:57 -0500 Recall Management /news/headline/2025-07-22-recall-issued-fda-certain-craniotomy-kits <p>The Food and Drug Administration has identified a Class I recall of certain lots of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/medical-procedure-kits-correction-medline-industries-lp-issues-correction-medline-craniotomy-kits" target="_blank">Medline Industries Craniotomy Kits</a> containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death. The recall was issued due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure. The recall involves correcting the devices and does not call for them to be removed from where they are used or sold. </p> Tue, 22 Jul 2025 14:16:51 -0500 Recall Management /news/headline/2025-07-21-fda-recalls-two-products-potential-serious-harm <p>The Food and Drug Administration July 21 identified Class I recalls of two products due to the potential for serious injury or death. <a href="https://www.fda.gov/medical-devices/medical-device-recalls/applicator-recall-integra-lifesciences-removes-micromyst-applicators-due-potential-sterility">Integra LifeSciences MicroMyst Applicators</a> were recalled due to incomplete bioburden assessments and sterilization location transfer documentation. The recall involves removing devices from where they are used or sold. <a href="https://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-respirator-correction-maquet-critical-care-ab-updates-use-instructions-servo">Maquet Critical Care AB Servo Ventilator Systems</a> were recalled due to a risk of an inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The recall involves updating instructions for using devices. </p> Mon, 21 Jul 2025 15:51:51 -0500 Recall Management /news/headline/2025-07-17-fda-announces-recall-cefazolin-sandoz-mislabeling <p>The Food and Drug Administration July 15 <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-sandoz-inc-issues-voluntary-nationwide-recall-expansion-one-additional-lot-cefazolin" title="FDA statement">announced</a> a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and potentially life-threatening health consequences. Sandoz has not received any reports of adverse events or injuries related to the mislabeling but has received a complaint of the mislabeled product being administered to a patient. </p> Thu, 17 Jul 2025 14:52:32 -0500 Recall Management /news/headline/2025-05-27-fda-issues-recall-tubes-used-manage-bleeding <p>The Food and Drug Administration has identified a <a href="https://www.fda.gov/medical-devices/medical-device-recalls/esophagogastric-tube-recall-bd-issues-correction-esophagogastric-balloon-tamponade-tubes-due" title="recall">Class I recall</a> of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries and one death associated with the issue. </p> Tue, 27 May 2025 15:09:16 -0500 Recall Management /news/headline/2025-04-24-recall-issued-aspiration-system-qapel-medical <p>The Food and Drug Administration has identified a <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072" target="_blank">Class I recall</a> of Q’Apel Medical 072 Aspiration System after the company submitted three device event reports that included a tip detachment, a vessel rupture and a vasospasm.</p> Thu, 24 Apr 2025 15:59:59 -0500 Recall Management /news/headline/2025-03-21-recall-issued-becton-dickinson-and-company-infusion-pump-adapters <p>The Food and Drug Administration has identified a Class I recall of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris" target="_blank">Becton, Dickinson and Company BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapters</a> due to reports that customers using Systems Manager software who are also connected to the system’s CCE Infusion Adapter may experience delayed system response and backlogging of automated programming requests. Outdated APRs may upload to the Alaris computer, presenting different rate, dose or volume parameters than the current infusion.</p> Fri, 21 Mar 2025 14:44:49 -0500 Recall Management /news/headline/2025-03-19-fda-issues-recall-medtronic-embolization-devices <p>The Food and Drug Administration has identified a Class I recall of <a href="https://www.fda.gov/medical-devices/medical-device-recalls/embolization-device-recall-and-correction-medtronic-removes-unused-027-compatible-pipeline-vantage" target="_blank">Medtronic Neurovascular 027 Compatible Pipeline Vantage Embolization Devices</a> due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures.</p> Wed, 19 Mar 2025 14:56:00 -0500 Recall Management /news/headline/2025-03-05-baxter-recalls-spectrum-infusion-pumps <p>The Food and Drug Administration March 5 <a href="https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-issue-baxter-healthcare-corporation">announced</a> that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws. The FDA said missing motor mounting screws could lead to insufficient or excessive therapy, interruption in therapy or delay in therapy, which can result in serious adverse health consequences. Baxter has reported one serious injury related to the issue.</p> Wed, 05 Mar 2025 15:21:35 -0600 Recall Management /news/headline/2024-05-17-fda-issues-import-alert-additional-recommendations-against-using-plastic-syringes-made-china <p>The Food and Drug Administration yesterday announced an <a href="https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication">import alert</a> for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes. The alert was issued for Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. for not meeting device quality system requirements.</p><p>The FDA recommends that users immediately transition away from using plastic syringes produced by those manufacturers, along with <a href="/news/headline/2024-03-20-fda-advises-against-using-plastic-syringes-made-china">those</a> made by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., unless absolutely necessary until users can transition to alternatives. The FDA continues to evaluate other Chinese-made plastic syringes and recommends not using them, if possible. </p> Fri, 17 May 2024 16:04:36 -0500 Recall Management