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 Name: Perseus A500 Product Codes: See Recall Database Entry Devices Recalled in the U.S.:…
DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley 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: GeoMed Custom Tracecarts Product Codes: LRO Model Numbers: 53-1829 Laminectomy Tracecart 53-1831 Ortho Total Joint Tracecart 53-1836 General Surgery Tracecart Distribution Dates: August 25, 2022…
Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency
Summary Company Announcement Date: April 23, 2024 FDA Publish Date: April 23, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Decreased Potency Company Name: Dr. Reddy’s Laboratories Inc Brand Name: Brand Name(s) Dr. Reddy’s Product Description: Product Description Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Company Announcement FOR IMMEDIATE RELEASE Hyderabad India…
FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication
Date Issued: April 22, 2024 The U.S. Food and Drug Administration (FDA) encourages the public to follow established choking rescue protocols, which are step-by-step guides, approved by the American Red Cross and the American Heart Association to relieve the airway obstruction in choking victims. These rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver)…
Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
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: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Product Codes: FRN…
Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
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 Name: Obsidio Conformable Embolic Product Codes: See Medical Device Recall Database Entry Distribution Dates:…
Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to Long-term Buildup Causing an Obstruction
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: HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) Product Codes: DSQ…
Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP
Summary Company Announcement Date: April 05, 2024 FDA Publish Date: April 08, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description The potential for a lack of sterility Company Name: Medline Industries, LP Brand Name: Brand Name(s) Medline and Centurion Product Description: Product Description Convenience kits Company Announcement Northfield, Ill., Apr. 5, 2024…
Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft
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: CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: GS9070SD; GS9080SD; GS9090SD; GS9095SD; Neurovascular guide catheter, single-use Product Codes: QJP Manufacturing Dates: July 7,…
Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station Due to a Lack of Appropriate Policies and Procedures by Honeywell’s Supplier
Summary Company Announcement Date: April 04, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-compliance with current good manufacturing practice (cGMP) requirements. Company Name: Honeywell Safety Products USA Brand Name: Brand Name(s) Fendall 2000 Product Description: Product Description Non-Sterile Eyewash Cartridge Company Announcement FOR IMMEDIATE RELEASE –…