Medical News

MedWatch Safety Alert FDA

Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences

Potential balloon burst during inflation can lead to embolism or the need for surgery.

2026-10-15 Read on FDA.gov →

MedWatch Safety Alert FDA

Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 13, 2026 – Par Health is recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, …

2026-10-14 Read on FDA.gov →

MedWatch Safety Alert FDA

Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall

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

2026-10-14 Read on FDA.gov →

MedWatch Safety Alert FDA

Convenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall

Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination

2026-10-13 Read on FDA.gov →

MedWatch Safety Alert FDA

Early Alert: Diagnostic Ultrasound System Issue from Philips Ultrasound

A software app or transducer connection problem with the Philips Lumify diagnostic ultrasound system can result in loss of or delays in scanning functionality.

2026-10-09 Read on FDA.gov →

MedWatch Safety Alert FDA

Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter

FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identif…

2026-10-09 Read on FDA.gov →

MedWatch Safety Alert FDA

Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets are being removed and discontinued; Alaris Pump Module model 8100 has updated performance data

2026-10-05 Read on FDA.gov →

MedWatch Safety Alert FDA

IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets

Black specks and particulate reported in drip chambers of certain ICU Medical IV tubing sets does not affect device safety, performance, or intended use.

2026-10-05 Read on FDA.gov →

MedWatch Safety Alert FDA

Breathing Circuit Recall: Draeger Removes VentStar Resus Neo Hoses

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

2026-10-02 Read on FDA.gov →

MedWatch Safety Alert FDA

Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels

IMMEDIATE RELEASE - Tomball, Texas – October 1, 2026 – Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potential elevated endotoxin levels.

2026-10-01 Read on FDA.gov →

MedWatch Safety Alert FDA

Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters

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

2026-09-25 Read on FDA.gov →

MedWatch Safety Alert FDA

Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules

BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules

2026-09-24 Read on FDA.gov →

MedWatch Safety Alert FDA

Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers

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

2026-09-24 Read on FDA.gov →

MedWatch Safety Alert FDA

Early Alert: Heart Pump Controller Issue from Abiomed

Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.

2026-09-23 Read on FDA.gov →

MedWatch Safety Alert FDA

Early Alert: Ventilator Issue from React Health

IFT cable connector on VOCSN devices may become unseated and lose communication with internal flow transducer board leading to reboots, System Fault 10 Alarms.

2026-09-23 Read on FDA.gov →

MedWatch Safety Alert FDA

Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matter

ROCHESTER, MI– September 18, 2026 –Par Health is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulos…

2026-09-21 Read on FDA.gov →

MedWatch Safety Alert FDA

Convenience Kit Correction: AVID Medical Issues Correction for Kits Containing Huons Sodium Chloride Ampules

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

2026-09-21 Read on FDA.gov →

MedWatch Safety Alert FDA

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain …

2026-09-21 Read on FDA.gov →

MedWatch Safety Alert FDA

Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets

The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.

2026-09-21 Read on FDA.gov →

MedWatch Safety Alert FDA

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

2026-09-18 Read on FDA.gov →

MedWatch Safety Alert FDA

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.

2026-09-18 Read on FDA.gov →

MedWatch Safety Alert FDA

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.

2026-09-15 Read on FDA.gov →