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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Name: Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter…
Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Figure 1: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Product Name: MEGADYNE MEGA SOFT Pediatric Patient…
Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Summary Company Announcement Date: June 11, 2024 FDA Publish Date: June 12, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Higher than acceptable microbiological mold count Company Name: Suntegrity Skincare Brand Name: Brand Name(s) Suntegrity Product Description: Product Description Sunscreen foundation Company Announcement FOR IMMEDIATE RELEASE – Jun 11, 2024 – Las Vegas,…
Male Enhancement Supplements Recalled
Summary Company Announcement Date: February 01, 2024 FDA Publish Date: June 11, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Product is tainted with sildenafil and tadalafil Company Name: Integrity Products Brand Name: Brand Name(s) Ram It, To The Moon Product Description: Product Description Dietary Supplements for Male Sexual Enhancement Company Announcement…
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
Summary Company Announcement Date: June 05, 2024 FDA Publish Date: June 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: HomeoCare Laboratories Inc. Brand Name: Brand Name(s) StellaLife Inc. Product Description: Product Description Homeopathic StellaLife Oral Care Products Company Announcement FOR IMMEDIATE RELEASE – Yonkers, NY, 06/05/2024 – HomeoCare…
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
Please be aware, this recall is a correction, not a product removal. 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 Product Name: StealthStation S8 Application Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 Devices Recalled in…
Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction
Summary Company Announcement Date: May 31, 2024 FDA Publish Date: May 31, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability to inflate. Company Name: Medline Industries LP…
OptumHealth Care Solutions Recalls Nimbus II Infusion Pump Systems Under Recall by InfuTronix, LLC
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 Product Name: Optum Nimbus II Plus Ambulatory Infusion System Product Codes: See Recall Database entry Distribution Dates: August 19, 2020 to April 20, 2024 Devices Recalled in…
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter
Summary Company Announcement Date: May 28, 2024 FDA Publish Date: May 29, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of particulate matter Company Name: Sagent Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Docetaxel Injection, USP Company Announcement FOR IMMEDIATE RELEASE – SCHAUMBURG, IL – May 28, 2024 –…
Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
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. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Names: BioZorb Marker Product Codes: NEU Model Numbers: F0405 BioZorb Marker 4cm x…