Murilo Freitas – Page 2

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

Murilo Freitas - 04:00, 14 de April de 2026109

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

rss

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development

Murilo Freitas - 13:00, 13 de April de 2026108

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development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

rss

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

Murilo Freitas - 04:00, 13 de April de 2026178

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

rss

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

Murilo Freitas - 04:00, 13 de April de 2026110

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

rss

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

Murilo Freitas - 15:54, 12 de April de 2026106

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

rss

Early Alert: Convenience Kit Issue from AVID Medical

Murilo Freitas - 04:00, 9 de April de 2026129

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

rss

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

Murilo Freitas - 04:00, 8 de April de 2026152

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

rss

Early Alert: Sizing Catheter Issue from Cook Medical

Murilo Freitas - 04:00, 8 de April de 2026127

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

rss

Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination

Murilo Freitas - 04:00, 7 de April de 2026150

Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-inc-issues-voluntary-nationwide-recall-wound-care-gel-products-due-microbial

rss

Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes

Murilo Freitas - 04:00, 2 de April de 2026222

Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/purge-cassette-recall-abiomed-removes-impella-heart-pump-purge-cassettes