Infusion Pump Recall: Infusion Pump Thermal Damage Issue from Smiths Medical

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product The FDA is aware that Smiths Medical…

Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs Due to Microbial Contamination

Summary Company Announcement Date: June 06, 2025 FDA Publish Date: June 06, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) Zicam® and Orajel™ Product Description: Product Description Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs Company Announcement Church…

Infusion Pump Recall: False Alarm Issue with Infusion Pump from Smiths Medical

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product   The FDA is aware that Smiths…

Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product  Product Names: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Unique Device…

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80 mg Only, Due to Microbial Contamination

Summary Company Announcement Date: June 02, 2025 FDA Publish Date: June 04, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Amneal Pharmaceutical LLC Brand Name: Brand Name(s) Product Description: Product Description Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg Company Announcement Amneal Pharmaceutical LLC, is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets,…

Cetirizine or Levocetirizine: Drug Safety Communication – FDA Warns About Risk of Severe Itching After Discontinuation of Long-Term Use of Allergy Medicines

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology ISSUE: The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over-the-counter (OTC) forms. The itching, also called pruritus, has been reported in patients who…

Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication

Date Issued: April 24, 2025 The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary Blood Collection tubes with the LeadCare Testing Systems. These tests may overestimate blood lead levels and…