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.
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2118) due to potential premature failure of Version 2 reprocessor connecting tube lock levers. The recall affects 1,259 units distributed worldwide.
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
Angiodynamics is recalling Soft-Vu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The defect affects 1,550 units distributed worldwide.
LSL Healthcare is recalling its Standard Central Line Dressing Change Kit (Model 2717J) because the included Webcol Large Alcohol Prep Pads were found to be non-sterile.
Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog Number 1050030) because the product may contain foreign matter, confirmed to be inspect fragments.
Uvlizer handheld UV-C germicidal wands may expose users and nearby people to ultraviolet radiation at levels above international safety guidelines for skin and eye protection.
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
Beckman Coulter is recalling Access Total T4 Calibrator lots because they produce falsely low patient results on DxI 600/800 instruments, potentially leading to unnecessary testing, delayed treatment for thyroid disorders, and incorrect dosing in pregnant patients.
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.