MedWatch Safety Alerts

Early Alert: Automated Compounding System Issue from Omnicell

Certain labels used with i.V.Station automated compounding systems may not be detected, leading to mislabeled sterile filled syringes

Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers

Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers

Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly

Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery

Early Alert: Convenience Kit Issue from Aligned Medical Solutions

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

Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps

Tandem is correcting Mobi insulin pumps operating on affected software versions (7.6.0.1, 7.6.0.3, and 7.7.0.1) which may incorrectly detect a motor issue

Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Namic Angiographic Rotating Adapter 10CC Control Syringe Placed into the Following Kits; AMS6908E Angio Pack, and AMS6908F Angio Pack

On April 02, 2026, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of two convenience kits that contain the Medline Namic Angiographic Rotating Adapter(RA

Early Alert: Convenience Kit Issue from American Contract Systems

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

Early Alert: Convenience Kit Issue from Medical Action Industries

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

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

Percussionaire Corporation issues updated instructions for ventilator tubes due to design defect that could cause hypoventilation, respiratory failure

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

Stryker is updating use instructions for TMJ Unilateral and Bilateral Implants due to a discrepancy in the positioning of the screw hole

Ventilator Correction: Philips Issues Correction for Trilogy Evo Platform Ventilators

Philips Trilogy Evo Ventilators may not function as intended if used with certain nebulizers

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

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

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

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

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

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

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

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

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

Aphreseller (Buy-herbal.com) Issues Voluntary Nationwide Recall of Kian Pee Wan Capsules Due the Presence of Undeclared Dexamethasone and Cyproheptadine

FOR IMMEDIATE RELEASE – 03/30/2026 - Flushing, New York, Aphreseller (Ebay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA

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