Summary Company Announcement Date: April 10, 2021 FDA Publish Date: April 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is contaminated with Burkholderia contaminans Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Sanit Technologies LLC d/b/a Durisan announces a voluntary…
Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Product Numbers: Medtronic HVAD Controller AC Adapter: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR,…
Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Medtronic Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Models: Full List of Affected Devices below Serial Numbers:…
Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product ThermaCor 1200 Disposable Sets Disposable Set Models: PTC-1200, DNC-1200, PNC-1200 Distribution Dates: 2006 to present Devices Recalled in the U.S.: 38,786 Date Initiated by Firm: February 21,…
Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: March 24, 2021 FDA Publish Date: March 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: Bit & Bet LLC Brand Name: Brand Name(s) Thumbs Up 7 Product Description: Product Description Blue 69K Dietary Supplement for male sexual enhancement Company Announcement Bit &…
Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Medtronic Valiant Navion Thoracic Stent Graft System Model Number, Product Codes, Catalog or Lot numbers: Please See Links Below. Distribution Dates: November 12, 2018 to February 10,…
NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to Presence of Undeclared Sildenafil and/or Tadalafil
Summary Company Announcement Date: April 08, 2021 FDA Publish Date: April 09, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and/or Tadalafil Company Name: NS NY Distributor Inc Brand Name: Brand Name(s) NS NY Distributor Inc Product Description: Product Description Premium Orgazen 7000 and Ginseng Power 5000 capsules Company Announcement NS…
FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
April 9, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention’s (CDC) National Institute…
Lamictal (lamotrigine): Drug Safety Communication – Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease
[Posted 03/31/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An 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 Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same drug class have…
Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: April 05, 2021 FDA Publish Date: April 06, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Yolo Studio Brand Name: Brand Name(s) PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Product Description: Product Description Dietary Supplement for male sexual enhancement Company Announcement…