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 Name UDI / Model Number Lot/Serial Numbers…
Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
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 Unique Device Identifier (UDI) Codman Disposable Perforator 14 mm 10381780513599 Codman Craniotomy Kit…
Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients
This recall involves updating instructions for using 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 Names:…
Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly
Craniotomy Kit DYNJ35349C 10888277858060 (EA), 40888277858061 (CASE) 24CBJ925, 24DBT405, 24FBO318 CRANI Accessory Pack DYNJ59270 10888277771512 (EA), 40888277771513 (CASE) 23JDB683, 23JDC548, 24ADB783, 24HDA822 CRANI PACK-LF DYNJ44805M 10195327506872 (EA), 40195327506873 (CASE) 23JBI747, 23KBL228, 24ABG696, 24CBM117, 24EBQ114, 24GBJ699 CRANIOTOMY KIT CDS982719V 10195327510831 (EA), 40195327510832 (CASE) 23KBP461, 23LBN381, 24ABB119, 24BBC547, 24BBI145 CRANIOTOMY KIT CDS982719W 10195327645090 (EA), 40195327645091 (CASE) 24DBS813…
Disposable Surgical Stapler Cartridge Correction: Ethicon Endo-Surgery, LLC Issues Correction for Endopath Echelon to Address Inadvertent Lockout During Surgical Procedures
This recall involve 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 Product Names: Endopath Echelon Vascular White Reload…
Arterial Cannula Recall: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure
This recall involves removing 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 Family Model Number UDI-DI OptiSite Arterial Perfusion Cannula OPTI16 00690103180558 OptiSite Arterial Perfusion Cannula OPTI18…
Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment
This recall involves removing 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 Q-Link 13, product code 3156509 Product is used with the following mobile lifts: Uno 102 EE…
Early Alert: Infusion Pump Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware Baxter has issued a letter…
Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns
This recall involves removing 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 Manufacturer’s Product Number (Catalog Number) Product Name (Description) UDI Number Lot Number Expiration Date 205000DS MicroMyst Applicator,…
Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels
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 What to Do Check product list to see if your product is affected Contact Dexcom…