Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
FDA recalls eTRAX Needle System Starter Kit 18G due to an error in sensor inspection and programming. The needle tip position may be incorrectly identified on the user interface.
Burlington Medical is recalling Wrap Aprons due to potential degradation of Xenolite 800 attenuation material over time. Approximately 5,198 units distributed worldwide are affected.
Infusion sets may contain dull or blunt needle tips that could be difficult to advance or break during insertion, creating potential complications.
Mentor's CPX 4 breast tissue expanders may contain dull or blunt needle tips that could break or resist advancement during saline injection, potentially hindering treatment.
Medtronic's Paradigm REAL-Time Veo insulin pumps (55,724 units) may deliver incorrect insulin amounts when elevated or lowered relative to the infusion site, risking severe low or high blood sugar episodes.
Burlington Medical, LLC is recalling leg wraps with Xenolite 800 material that may degrade over time and lose effectiveness. The recall affects 103 units distributed worldwide.
Intuitive Surgical is recalling da Vinci S and Si Mega Needle Driver Instruments due to broken or frayed grip cables. The defect could impair surgeon control during surgical procedures.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently on the Allura Xper FD20/15 OR Table when using the wired foot switch. This malfunction could impact imaging-guided surgical procedures.
Civco Medical Instruments is recalling eTRAX Needle Sensor - 18G units due to an inspection and programming error that may cause incorrect needle tip position identification on the user interface.
The MiniMed 620G insulin pump may deliver incorrect insulin amounts when the pump is raised or lowered relative to where it's inserted, risking severe low or high blood sugar and serious complications.
Philips Azurion 3 M12 X-ray systems are recalled due to wired foot switch malfunction that may prevent or interrupt X-ray imaging initiation. A total of 298 units are affected.
Philips recalled Azurion 7 B20 X-ray systems due to foot switch malfunction that may prevent imaging initiation. Affects 1,523 units worldwide.
Medline's Airway Exam Kit (DYKE1796) is being recalled due to a defect in included Olympus biopsy valves. Rubber fragments may detach into the patient's airway, potentially requiring emergency intervention.
Civco Medical Instruments recalls eTRAX Needle Sensor - 14G due to a programming error that may cause incorrect needle position display on the user interface.
The Azurion 5 M12 X-ray imaging system may fail to initiate imaging or operate intermittently when using the wired foot switch. Philips is recalling 345 units distributed in the US and internationally.
The eTRAX Needle System Starter Kit 14G may display an incorrect needle tip position due to an inspection and programming error affecting six units.
Medtronic MiniMed's insulin pumps may deliver incorrect insulin doses when the pump position changes relative to the infusion site, potentially causing dangerous blood sugar swings. Both over-delivery and under-delivery can result in severe complications or death.
Olympus is recalling SOLTIVE laser systems due to a potential 24V power supply defect that could cause system malfunction, smoke, or burning smell. The fire risk is contained by design and self-extinguishing.
Mentor Texas is recalling CPX 4 US Breast Tissue Expanders due to dull or blunt needle tips that may be difficult to advance or break during implantation.
Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps are recalled because they can deliver incorrect insulin amounts when the pump height changes relative to the infusion site, risking severe low or high blood sugar.
Burlington Medical is recalling Kilt Blockers due to potential degradation of the Xenolite 800 attenuation material over time, which may reduce the product's protective lifespan.
Medline is recalling 14,379 kits containing Olympus biopsy valves due to rubber fragments that may detach and lodge in a patient's airway. The detachment may require surgical removal and could cause inflammation or reduced oxygen levels.
Cardinal Health is recalling 198,900 units of Monoject Tuberculin Syringes because packages labeled as Tuberculin Syringes contain U-100 Insulin syringes instead. This mislabeling could lead to dosing or injection errors.
Azurion 5 M20 X-ray systems may fail to start imaging due to wired foot switch malfunction. No injuries reported.
JFE Franchising Inc is recalling Dumpling Vegetable and Loaded Dumpling Vegetable products due to the presence of glass fragments. The products were distributed across multiple U.S. states.