December 2, 2021 Update: The FDA launched a new web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The new web page includes: Paclitaxel-coated balloons and stents approved in the United States Current recommendations for health care providers Risks associated with paclitaxel-coated balloons…
UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. On November 30, 2021, NuVasive issued a field safety notice to inform…
Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR
Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated Brand Name: Brand Name(s) Product Description: Product Description Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR Company Announcement WAYNE, Pa.,…
P&G Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray Products Due to Detection of Benzene
Summary Company Announcement Date: November 23, 2021 FDA Publish Date: November 23, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of benzene Company Name: The Proctor & Gamble Company Brand Name: Brand Name(s) Old Spice Secret Product Description: Product Description Old Spice and Secret Aerosol Sprays Company Announcement The…
Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance
Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Sagent Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Levetiracetam Injection Company Announcement CHICAGO, IL – November 19, 2021 – Sagent Pharmaceuticals, Inc. today announced…
American Screening LLC issues a Voluntary Nationwide Recall of American Screening Hand Sanitizer Packaged in 8 oz Bottles Because They Resemble Beverage Containers
Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption Company Name: American Screening LLC Brand Name: Brand Name(s) American Screening Product Description: Product Description Hand…
Odor-Eaters® Issues Voluntary Nationwide Recall of Specific Lots of Odor- Eaters® Spray Powder and Odor-Eaters® Stink Stoppers® Spray Due to Benzene Contamination
Summary Company Announcement Date: November 17, 2021 FDA Publish Date: November 17, 2021 Product Type: CosmeticsDrugs Reason for Announcement: Recall Reason Description Due to the presence of benzene Company Name: Odor-Eaters®, owned by Blistex Inc. Brand Name: Brand Name(s) Odor-Eaters® Product Description: Product Description Oder Eaters spray products Company Announcement Odor-Eaters®, owned by Blistex Inc.,…
Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation – Letter to Health Care Providers
November 17, 2021 The U.S. Food and Drug Administration (FDA) is reminding providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. Cardiac perforation is a rare complication of any pacemaker system implant. Cardiac perforation can lead to major complications or even death. The overall risk of cardiac perforation associated…
SterRx, LLC Issues Voluntary Nationwide Recall of Certain SterRx Products
Summary Company Announcement Date: November 12, 2021 FDA Publish Date: November 15, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: SterRx, LLC Brand Name: Brand Name(s) SterRx, LLC Product Description: Product Description SterRx products intended to be sterile Company Announcement SterRx, LLC today announced the voluntary nationwide…
Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
Date Issued: 11/12/2021 The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from…