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…
A Recipe for Danger: Social Media Challenges Involving Medicines
[embedded content] Social media trends and peer pressure can be a dangerous combination to your children and their friends, especially when involving misusing medicines. One social media trend relying on peer pressure is online video clips of people misusing nonprescription medications and encouraging viewers to do so too. These video challenges, which often target youths,…
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…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand…
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…
FDA D.I.S.C.O. Burst Edition: Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on two recent FDA cancer drug approvals. On August 10, 2022, the FDA granted regular approval to…
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…
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Date Issued: September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) 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….