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.
TG FOODS INC is recalling Divided Sunset Multi Collagen Peptides (8 oz) because the product contains eggshell membrane collagen and wild-caught marine collagen but fails to declare EGG and the specific fish species on the label.
Mentor Texas is recalling CPX 4 breast tissue expanders due to potentially dull or blunt infusion set needles that may be difficult to insert or may break during use.
Mentor Texas, LP is recalling Artoura Breast Tissue Expanders due to infusion sets that may contain dull or blunt needle tips, which may be difficult to advance and could break during use.
ReCor Medical is recalling the Paradise Ultrasound Renal Denervation System catheter (Lot M4862) because it distributed 24 nonconforming units that were not approved for human use.
Medline is recalling 14,379 surgical procedure kits containing Olympus biopsy valves that may shed rubber fragments during use, potentially creating airway obstruction.
Philips is recalling the ALLURA Xper FD20 OR Table because the wired foot switch may fail to initiate X-ray imaging or cause imaging to occur intermittently, which could delay critical diagnostic imaging during surgery.
MiniMed 530G insulin pumps may deliver too much or too little insulin when positioned above or below the injection site, potentially causing dangerously high or low blood sugar.
Oxoid's Microbact 12L Listeria Identification Kit (lot 4494873) may provide incorrect organism identification results due to ambiguous color reactions in test wells. Two kits were distributed nationwide in Georgia and California.
Burlington Medical recalls Demi Half Aprons due to potential degradation of Xenolite 800 radiation-shielding material over time. The recall affects 29 units manufactured between January 16, 2025, and January 21, 2026.
Philips has identified a foot-switch malfunction on ALLURA Xper FD10F X-ray systems that may prevent imaging from starting or cause intermittent operation. The defect affects 10 systems and risks delaying diagnostic procedures.
Siemens is recalling Atellica CH A1c test kits that may produce depressed results when used with RCRP on the same analyzer. This could delay diabetes diagnosis or result in inadequate treatment decisions.
Medline recalls 9,040 ENFIT G-tube connector kits due to manufacturing defects preventing proper sealing and causing leakage, risking delayed care. Over-tightening to prevent leakage risks infection and additional clinical complications.
Burlington Medical is recalling Protective Sleeves due to potential attenuation material degradation. The issue affects approximately 1,129 units distributed worldwide.
Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor surgical instruments due to increased reports of broken or frayed grip cables. Approximately 2,660 affected units have been distributed worldwide.
Civco is recalling eTRAX Needle Sensors due to a programming error that could cause the needle tip position to be incorrectly identified on the user interface.
The Azurion 7 M12 X-ray imaging system may fail to initiate imaging or may operate intermittently due to a wired foot switch malfunction. No patient injuries have been reported.
Philips Azurion 3 M15 X-ray imaging systems are being recalled because the wired foot switch malfunction may prevent X-ray imaging from initiating or cause imaging to occur intermittently. Approximately 798 units have been distributed in the United States and internationally.
The eTRAX Needle System Starter Kit 12G contains a programming error in its needle sensor that can cause incorrect needle tip position display on the user interface. Civco Medical Instruments is recalling affected units.
Medtronic MiniMed 630G insulin pumps may deliver incorrect insulin doses when elevated or lowered relative to the infusion site, potentially causing severe hypoglycemia, seizures, or death.
Mentor Texas is recalling Artoura Breast Tissue Expanders because their infusion sets contain dull or blunt needle tips that may be difficult to advance and may break during use.
The Philips Allura Xper FD20/15 X-ray imaging system may fail to initiate or may initiate intermittently when using the wired foot switch. Philips is recalling 296 affected units (68 in the US, 228 internationally) to address this functional defect.
Stryker surgical light assemblies may not adequately support the ceiling cover weight, creating a fall risk. The Class II recall affects 6,170 units distributed worldwide.
Philips is recalling 111 Allura Xper FD20/20 X-ray imaging systems due to a wired foot switch defect that may prevent imaging from being initiated or cause intermittent operation.
The ALLURA Xper FD10 X-ray imaging system may fail to initiate imaging or operate intermittently when using the wired foot switch. A total of 2,291 units are affected.
Philips has recalled the Allura Xper FD20/20 operating room X-ray table due to wired foot switch defects that may prevent or intermittently delay X-ray imaging. Five affected units have been distributed internationally.