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.
Uvlizer handheld UV-C wands may expose users and bystanders to ultraviolet-C radiation levels above international safety limits during normal use, posing risk of skin and eye injury.
Pending LLM rewrite. Source: FDA_DEVICE Z-1940-2026.
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
Pending LLM rewrite. Source: FDA_DEVICE Z-1915-2026.
Remel Europe Ltd. is recalling specific lots of Oxoid Agglutinating Sera, Salmonella 9-0 due to cross-reactivity that may misidentify Salmonella 9-O serotypes as 2-O serotypes in laboratory testing.
Arrow International is recalling FlexTip Plus Epidural Catheter and FlexBlock Continuous Peripheral Nerve Block Catheter Kits due to incorrect manufacturing of liquid adhesive. The recall affects 190 units distributed nationwide.
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Pending LLM rewrite. Source: FDA_FOOD H-0670-2026.
LSL Healthcare's Central Line Dressing Kit (Model 2717H) is being recalled because it contains Webcol Large Alcohol Prep Pads that were found to be non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.
Pending LLM rewrite. Source: FDA_FOOD H-0671-2026.
Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects 270,311 units distributed nationwide and internationally.
Pending LLM rewrite. Source: FDA_FOOD H-0672-2026.
Arrow International is recalling 115 units of its percutaneous sheath introducer with 7.5–8 Fr catheter because the liquid adhesive was incorrectly manufactured by a supplier. The product is used for venous access and central circulation catheterization.
Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.
LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.
Pending LLM rewrite. Source: FDA_FOOD H-0666-2026.
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Kumpe, Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Pending LLM rewrite. Source: FDA_DEVICE Z-1883-2026.
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up testing.
Pending LLM rewrite. Source: FDA_DEVICE Z-1859-2026.