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 Name: Speed Control Dial Component Used with the SmartDrive MX2+ Power Assist Device Part…
Ascent Consumer Products Inc. Issues Voluntary Nationwide Recall of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Due to Microbial Contamination
Summary Company Announcement Date: February 25, 2025 FDA Publish Date: February 25, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination of the product with Staphylococcus aureus (S. aureus) Company Name: Ascent Consumer Products Inc. Brand Name: Brand Name(s) SinuCleanse Product Description: Product Description Soft Tip Squeeze Bottle Nasal Wash System Company…
Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
This recall involves the potential need for device explant. 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 following the What to Do section below. Affected Product Product Names: ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR)…
One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Summary Company Announcement Date: February 20, 2025 FDA Publish Date: February 20, 2025 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Tadalafil Company Name: One Source Nutrition Brand Name: Brand Name(s) Product Description: Product Description Vitality male enhancement dietary supplement capsules Company Announcement FOR IMMEDIATE RELEASE – Benton, Arkansas –…
BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination
Summary Company Announcement Date: February 15, 2025 FDA Publish Date: February 18, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides Company Name: BD Brand Name: Brand Name(s) Product Description: Product Description ChloraPrep Clear 1 mL applicator skin preparation product…
Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
This recall involves updating instructions for using 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 following the updated instructions. Affected Product Product…
ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling
Summary Company Announcement Date: February 13, 2025 FDA Publish Date: February 14, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. Company Name: ICU Medical Brand Name: Brand Name(s) ICU Medical Product Description: Product Description POTASSIUM…
Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
This recall involves correcting 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 Product Names StatStrip Glucose Hospital Meter System StatStrip…
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
Date Issued: January 30, 2025 The U.S. Food and Drug Administration (FDA) is raising awareness among health care providers, health care facilities, patients, and caregivers that cybersecurity vulnerabilities in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors (which are Contec CMS8000 patient monitors relabeled as MN-120) may put patients at risk after being connected…
Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System
Summary Company Announcement Date: January 31, 2025 FDA Publish Date: January 31, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch Company Name: Alvogen, Inc. Brand Name: Brand Name(s) Product Description: Product Description Fentanyl…