Summary Company Announcement Date: September 17, 2022 FDA Publish Date: September 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains benzene Company Name: Salon Technologies International Inc. Brand Name: Brand Name(s) Antica Farmacista Product Description: Product Description Ocean Citron Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – September 16, 2022 –…
Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction
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: NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube Model Numbers: See recall database entry Devices Being Recalled in the…
Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements
Summary Company Announcement Date: September 15, 2022 FDA Publish Date: September 16, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product was stored outside of labeled temperature requirements Company Name: Family Dollar Brand Name: Brand Name(s) Product Description: Product Description Toothpaste Company Announcement Family Dollar is initiating a voluntary retail level product recall…
Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 16, 2022 The U.S. Food and Drug Administration (FDA) is updating the Letter to Health Care Providers issued on April 27, 2022, to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic for the risk of airway obstruction with the NIM CONTACT Reinforced EMG Endotracheal…
Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements
Summary Company Announcement Date: August 05, 2022 FDA Publish Date: September 16, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product was stored outside of labeled temperature requirements. Company Name: Family Dollar Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Various OTC medical products Company Announcement Family Dollar is…
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
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: Clearlink Basic Solution Set with Duovent Product Code: 2R8403 (all lots within expiry) Devices in U.S. Distribution: 511,728 Dates distributed: October 14, 2020 to June…
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers
September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have…
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication
Date Issued: September 8, 2022 The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as…
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device Correction to inform health care providers about the issue. An increased rate of reports of clip lock…
Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury
Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips Respironics Brand Name: Brand Name(s) Product Description: Product Description Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or…