The HeartWare HVAD System is used in patients with heart failure. The Instructions for Use and Patient Manual Will be Updated to Address System Issues.
Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil. Tadalafil and sildenafil are drugs known as phosphodiesterase (PDE-5) inhibitors found in FDA approved
Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts product
Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.
Hospira, Inc., a Pfizer company, is voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the other
Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing h
The Alaris Pump Bezel Assembly from Pacific Medical Group is used to repair and service infusion pump modules. Over time, the bezel repair posts may crack or break.
Scentsational Soaps & Candles, Inc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bot
The Precise PRO Rx US Carotid System is used in patients with narrowing carotid arteries. There is a recall due to risk of separation at a specific point.
BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily recalling specified lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level due to a defective applicator.
The Bio-Console 560 controls a blood pump during cardiopulmonary bypass or ECMO. An electrical failure in the console may cause the pump to stop.
On February 24th, 2021, Tenacore LLC initiated a nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e
The Tenacore Alaris Pump Bezel Assembly services and repairs Alaris infusion pump modules. Over time, the bezel repair posts may crack or separate.
Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination.
The Alaris System is a fluid delivery system. The keys may become stuck or unresponsive and may lead to an infusion delay or delay in care.
The HeartWare HVAD System pump is used in patients with heart failure. Some pumps may stop because of damaged controller ports
The ThermaCor 1200 Disposable Sets are part of a portable fluid delivery device system and are being recalled for patient aluminum contact risk.
Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia ICDs and CRT-Ds correct heart arrhythmia. Some devices may have shortened battery life.
NS NY Distributor Inc is voluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5)
The Medtronic Stent Graft System is used to repair descending thoracic aortic aneurysm. Use of the device may lead to stent fractures and endoleaks.