Date Issued: April 12, 2023 The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. The FDA is aware of laboratory test results…
Actualización sobre reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno: Comunicado de seguridad de la FDA
English Fecha de publicación: 8 de marzo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando una actualización sobre los reportes de carcinoma de células escamosas (SCC, por sus siglas en inglés) en el tejido cicatricial (cápsula) que se forma alrededor de los implantes…
Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
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: Philips Respironics DreamStation1 (Uno Remediated Devices) Product Models: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto…
Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire
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: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System Product Models: all Reader…
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS Product Description: Product Description Alcohol Antiseptic 80% Topical Solution…
Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.
Summary Company Announcement Date: April 03, 2023 FDA Publish Date: April 03, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for battery swelling and overheating. Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Readers in the FreeStyle Libre product family. Company Announcement This communication applies to the Readers…
Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply Product Description: Product Description Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product
Summary Company Announcement Date: March 13, 2023 FDA Publish Date: March 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Bacillus cereus Contamination Company Name: Camber Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device & Drug Safety/Microbial Contamination/Bacillus cereus Company Announcement FOR IMMEDIATE RELEASE – 3/13/2023 – Piscataway, NJ,…
Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to January 13, 2023 Devices…
Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
Date Issued: March 30, 2023 The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The devices of concern include: Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance…