MedWatch Safety Alerts

Nitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery System

The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy

Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules

Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co,. Ltd

Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device

The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device

Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels

FOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable

Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules

Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules

BMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect

On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600

Monitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software

Patients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in

Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed

Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support

Early Alert: Breathing Circuit Issue from Draeger

Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy

Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead

Infinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement

Early Alert: Convenience Kit Issue from AVID Medical

AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules

Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators

Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile

Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis

Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits

Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector

Ana Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to

Early Alert: IV Start Kit Issue from Avid Medical

Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.

Early Alert: Angiographic Catheter Issue from Boston Scientific

Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism

Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds

AVID Medical is correcting convenience kits containing Manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall

Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System

ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use.