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Ventilator Tubing Correction: Percussionaire Corporation Updates Use Instructions for Phasitron In-Line Valve

Murilo Freitas - 04:00, 14 de April de 202684
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Percussionaire Corporation issues updated instructions for ventilator tubes due to design defect that could cause hypoventilation, respiratory failure

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-tubing-correction-percussionaire-corporation-updates-use-instructions-phasitron-line

 
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Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators

Murilo Freitas - 04:00, 14 de April de 2026110
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Philips Trilogy Evo Ventilators may not function as intended if used with certain nebulizers.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-correction-philips-issues-correction-trilogy-evo-platform-ventilators

 
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Reconstruction Prosthesis Correction: Stryker Updates Use Instructions for Patient-Fitted TMJ Implants

Murilo Freitas - 04:00, 14 de April de 2026112
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Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/reconstruction-prosthesis-correction-stryker-updates-use-instructions-patient-fitted-tmj-implants

 
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FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development

Murilo Freitas - 13:00, 13 de April de 2026111
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FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-genome-editing-safety-standards-advance-gene-therapy-development

 
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Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer

Murilo Freitas - 04:00, 13 de April de 2026181
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The Merit 16F Dual-Valved Splittable Sheath Introducer may not split as intended. This may cause bleeding, embolization, or loss of vessel for future access.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/dialysis-catheter-recall-merit-medical-removes-16f-dual-valved-splittable-sheath-introducer

 
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Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL

Murilo Freitas - 04:00, 13 de April de 2026113
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Draeger corrects the Atlan A350, A350 XL for piston ventilator failures and mechanical ventilation issues due to manufacturing impurities

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/anesthesia-workstation-correction-draeger-issues-correction-atlan-a350-and-a350-xl

 
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FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

Murilo Freitas - 15:54, 12 de April de 2026109
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FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
http://www.fda.gov/news-events/press-announcements/fda-reminds-more-2200-sponsors-and-researchers-disclose-trial-results

 
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Early Alert: Convenience Kit Issue from AVID Medical

Murilo Freitas - 04:00, 9 de April de 2026131
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The adaptor on Namic RA syringes may unwind during use. The resulting loose connection or disconnection may lead to infection, blood loss, or air embolism.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-convenience-kit-issue-avid-medical

 
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Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits

Murilo Freitas - 04:00, 8 de April de 2026154
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When the Volara system is used in a home setting, there is a risk for oxygen desaturation or barotrauma if it is used in-line with a ventilator. 

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/ventilator-correction-baxter-updates-use-instructions-volara-single-patient-use-circuits

 
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Early Alert: Sizing Catheter Issue from Cook Medical

Murilo Freitas - 04:00, 8 de April de 2026128
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When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-sizing-catheter-issue-cook-medical

 
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