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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.
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Anesthesia Workstation Correction: Draeger Issues Correction for Atlan A350 and A350 XL
Draeger corrects the Atlan A350, A350 XL for piston ventilator failures and mechanical ventilation issues due to manufacturing impurities
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FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
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
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.
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Ventilator Correction: Baxter Updates Use Instructions for Volara Single-Patient Use Circuits
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.
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Early Alert: Sizing Catheter Issue from Cook Medical
When the sizing catheters are used during angiographic procedures the marker bands may be at an increased risk of cracking/breakage.
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Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
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.
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Purge Cassette Recall: Abiomed Removes Impella Heart Pump Purge Cassettes
Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops.
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Heart Pump Correction: Abiomed Updates Use Instructions for Impella RP with SmartAssist Devices
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.
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FDA Approves First New Molecular Entity Under National Priority Voucher Program
FDA Approves First New Molecular Entity Under National Priority Voucher Program
http://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program