Summary Company Announcement Date: February 01, 2024 FDA Publish Date: February 02, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Company Announcement TARRYTOWN, N.Y.–(GLOBE NEWSWIRE)-February 1, 2024—Insight Pharmaceuticals, a Prestige…
Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error
Please be aware, this recall is a correction, not a product removal. 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 (Include the following information) Product Names: ExcelsiusGPS Product Codes: OLO Part number: 6203.2100 Distribution Dates:…
Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist
Please be aware, this recall is a correction, not a product removal. 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 Names: Atrium Express Dry Suction Dry Seal Chest Drain Product Codes: CAC Model Numbers:…
Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release
Summary Company Announcement Date: January 19, 2024 FDA Publish Date: January 22, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety Potential Safety Concerns Company Name: Kilitch Healthcare India Limited Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Lubricant Eye Drops & Multi-Symptom Eye Drops Company Announcement The…
Prolia (denosumab): Drug Safety Communication – FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
[Posted 01/19/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Nephrology, Pharmacy ISSUE: Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. Severe hypocalcemia appears to be more…
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Date Issued: January 18, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP)….
Risks with Exactech Equinoxe Shoulder System with Defective Packaging – FDA Safety Communication
314-01-02 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small 10885862084408 314-01-03 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium 10885862084415 314-01-04 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large 10885862084422 314-01-12 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small 10885862084439 314-01-13 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53…
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
Please be aware, this recall is a correction, not a product removal. 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 Names: Regard Operative Lap P&S Surgical Kit Product Codes: LRO – See Recall Database…
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
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 Names: Tracheostomy Care Kit, Dressing Change Kit, and Tracheostomy Care Set Product Codes: NXA, MCY – See Recall Database Entry: Model Numbers: Catalog No. 800 TRACHEOSTOMY…
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
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 Names: Ivenix Large Volume Pump Product Codes: FRN Model Numbers: LVP-0004 Distribution Dates: October 1, 2021 to July 31, 2023 Devices Recalled in the U.S.: 938…