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…
Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use
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 Names: Twin Tube Product Codes: BZC Model Numbers: V-707327 Distribution Dates: January 1, 2015 to June 30, 2023 Devices Recalled in the U.S.: 649 Date Initiated…
Hospira Inc. Issues A Voluntary Nationwide Recall For Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units Due to the Potential for Incomplete Crimp Seals
Summary Company Announcement Date: May 21, 2024 FDA Publish Date: May 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Potential Packaging Defect Company Name: Hospira Inc. Brand Name: Brand Name(s) Product Description: Product Description Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units Company…
Abbott Recalls HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System Between Inflow Cannula and Apical Cuff
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: HeartMate 3 Left Ventricular Assist System Implant Kit Product Codes: See Recall…
Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without the software update may cause serious injuries or death….