The FDA wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes.
The FDA is informing patients, caregivers, and health care providers about reported differences in complication rates among Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction.
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).
The FDA is alerting patients who had mammograms at Tennessee Women?s Care P.C., located in Nashville, Tennessee, on or after November 1, 2019, about possible problems with the quality of their mammograms.
Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7 Blue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved produc
Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 70K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA appro
Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors,
Abuse and misuse of OTC nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization, disability, or death.
S&B Shopper LLC is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approv
Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50
Affinity Pixie Oxygenator and CVR are used in pediatric patients for cardiopulmonary bypass. Affected devices may cause more exposure to endotoxins.
PNHC, LLC, d/b/a Heal the World, is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect any other Hand Sanitizer products f
ACIST Kodama Intravascular Ultrasound Catheter images the arteries. Some catheters may get damaged and the pieces may flush into the arteries during use.
The FDA is informing patients, caregivers and health care providers of risk of device component breaking in patients with Stryker?s STAR Ankle Replacements.
Leaking assay tubes and abnormal PCR cycling can cause erroneous results. Read the letter for recommendations.
Combat Medical convenience kits are used for field typing, blood collection, and blood transfusion. A bent or disconnected needle may prevent the kit from working properly.
Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of Spironolactone tablets (four different lots) to the consumer level.
The FDA is alerting consumers, health care providers and users that improper use of thermal imaging devices may provide inaccurate temperature readings.
The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients.
The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room.
EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm.
The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Adamssecret.co is voluntarily recalling all lots within expiry of Adam?s Secret Extra Strength 1500 and Adam?s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafi
EMBLEM S-ICD Subcutaneous Electrode (Model 3501) is part of the Boston Scientific S-ICD System that helps detect heart activity and provides defibrillation therapy.
The FDA is informing that recent literature indicates that certain features are associated with better performance.