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 Medical Action Industries, Inc. 306 Medical Convenience Kits Kit Models and Lot Numbers: Please see links below. Distribution Dates: December 12, 2019 to March 22, 2021 Devices Recalled…
Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
[embedded content] Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common of all cancers. Skin cancer is on…
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
Date Issued: May 20, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a…
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration
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 VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018…
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
Date Issued: May 21, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more recent mammogram at a different…
Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by HAIOU – Letter to Health Care Providers
May 20, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care facility risk managers, procurement staff, and health care providers stop using certain syringes and needles with needle safety devices manufactured by Guangdong Haiou Medical Apparatus Co., LTD. (HAIOU) at this time while FDA continues our evaluation. The FDA received information about quality…
Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Expanded Recall of Dibar Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)
Summary Company Announcement Date: May 18, 2021 FDA Publish Date: May 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Dibar Nutricional S. de R.L. de C.V. Brand Name: Brand Name(s) DIBAR Labs, ProtectoRx Product Description: Product Description Hand Sanitizer Company Announcement Morelia, Michoacán, Mexico,Dibar Nutricional S. de…
Recall Expansion of Durisan Non-Alcohol Hand Sanitizer
Summary Company Announcement Date: May 14, 2021 FDA Publish Date: May 17, 2021 Product Type: Drugs Contaminants Reason for Announcement: Recall Reason Description Product is contaminated with Burkholderia contaminans Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Sanit Technologies LLC d/b/a Durisan is updating…
Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions
Summary Company Announcement Date: May 07, 2021 FDA Publish Date: May 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to improper storage temperature conditions Company Name: Novo Nordisk Brand Name: Brand Name(s) Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Description: Product Description Product Samples Company Announcement Novo Nordisk is voluntarily recalling…
Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol
Summary Company Announcement Date: May 12, 2021 FDA Publish Date: May 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Global Sanitizers Brand Name: Brand Name(s) Medically Minded Product Description: Product Description Hand Sanitizer Company Announcement Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of…