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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.
Author: FDA
Posted: April 20, 2021, 4:00 am
List of Medical Device recalls in 2021.
Author: FDA
Posted: April 20, 2021, 4:00 am
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.
Author: FDA
Posted: April 20, 2021, 4:00 am
The Tenacore Alaris Pump Bezel Assembly services and repairs Alaris infusion pump modules. Over time, the bezel repair posts may crack or separate.
Author: FDA
Posted: April 19, 2021, 4:00 am
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
Author: FDA
Posted: April 19, 2021, 4:00 am
The HeartWare HVAD System pump is used in patients with heart failure. Some pumps may stop because of damaged controller ports
Author: FDA
Posted: April 16, 2021, 4:00 am
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.
Author: FDA
Posted: April 16, 2021, 4:00 am
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.
Author: FDA
Posted: April 16, 2021, 4:00 am
Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia ICDs and CRT-Ds correct heart arrhythmia. Some devices may have shortened battery life.
Author: FDA
Posted: April 12, 2021, 4:00 am
The ThermaCor 1200 Disposable Sets are part of a portable fluid delivery device system and are being recalled for patient aluminum contact risk.
Author: FDA
Posted: April 12, 2021, 4:00 am
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)
Author: FDA
Posted: April 9, 2021, 4:00 am
Read more on the domestic supply of new respirators, including N95s and other FFRs, elastomeric respirators, powered air-purifying respirators (PAPRs)
Author: FDA
Posted: April 9, 2021, 4:00 am
The Medtronic Stent Graft System is used to repair descending thoracic aortic aneurysm. Use of the device may lead to stent fractures and endoleaks.
Author: FDA
Posted: April 9, 2021, 4:00 am
Cliffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) in
Author: FDA
Posted: April 6, 2021, 4:00 am
Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil a
Author: FDA
Posted: April 5, 2021, 4:00 am
Libertyville, IL, A-S Medication Solutions, LLC (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is being con
Author: FDA
Posted: April 2, 2021, 4:00 am
The FDA wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes.
Author: FDA
Posted: April 1, 2021, 4:00 am
Nuri Trading is voluntarily recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level.FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/orvardenafil.Sildenafil,tadalafil
Author: FDA
Posted: March 31, 2021, 4:00 am
FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (Lamictal).
Author: FDA
Posted: March 31, 2021, 4:00 am
Palisades Park, NJ, Ummzy LLC is voluntarily recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Nightcapsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil sildenafil & Vardenafil. Tadalafil, Sildenafil & Vardenafil are ingredientsknown as
Author: FDA
Posted: March 31, 2021, 4:00 am