AccessCardiology | McGraw Hill Medical

June 05, 2024 at 12:00 AM

HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination

HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.

June 05, 2024 at 12:00 AM

Medtronic Recalls StealthStation S8 Application Versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May Cause Incorrect Measurements During Cranial Surgery

The software error may cause numbers or letters to be missing from the displayed text and may result in the mechanical depth stop being set too short or too long.

June 05, 2024 at 12:00 AM

2024 Medical Device Recalls

June 03, 2024 at 12:00 AM

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

May 31, 2024 at 12:00 AM

Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction

On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, l

May 30, 2024 at 12:00 AM

2024 Medical Device Recalls

May 30, 2024 at 12:00 AM

OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC

Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death.

May 29, 2024 at 12:00 AM

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter

Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injec

May 23, 2024 at 12:00 AM

Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use

Vyaire Medical recalls Twin Tube due to potential nozzle separation risk posing a choking hazard.

May 23, 2024 at 12:00 AM

2024 Medical Device Recalls

May 23, 2024 at 12:00 AM

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

May 22, 2024 at 12:00 AM

BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication

FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others.

May 22, 2024 at 12:00 AM

2024 Medical Device Recalls

May 22, 2024 at 12:00 AM

Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals

Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incompl

May 22, 2024 at 12:00 AM

Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices.

May 21, 2024 at 12:00 AM

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

May 16, 2024 at 12:00 AM

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

May 15, 2024 at 12:00 AM

BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations

BioMérieux is recalling their VITEK 2 AST cards, used for testing bacterial sensitivity to antibiotics, due to excessive Ceftriaxone in two wells.

May 15, 2024 at 12:00 AM

Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power

The Perseus A500 that provides anesthesia and/or ventilation during surgical or diagnostic procedures may unexpectedly shutdown while using battery power.

May 15, 2024 at 12:00 AM

2024 Medical Device Recalls

May 15, 2024 at 12:00 AM

Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff

The HeartMate 3 Left Ventricular Assist System may allow blood to leak out or air to enter the system during implant of the LVAD device.

May 13, 2024 at 12:00 AM

Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance.

May 13, 2024 at 12:00 AM

2024 Medical Device Recalls

May 13, 2024 at 12:00 AM

2024 Safety Communications

Listing of Medical Device 2024 Safety Communications

May 13, 2024 at 12:00 AM

Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction

Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation.

FDA MedWatch