FDAMay 10, 2018device
BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
What to do
FDA enforcement status: Terminated
Brands named
angiodynamics inc navilyst medical incangiodynamicsangiodynamics inc
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCFlaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards2026-07-09
- CPSCArizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by 7111495 Canada2026-06-18
- FDAGSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.2026-05-29
- CPSCMiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming2026-05-28
- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDAPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Elev...2026-05-18
- FDAPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # ...2026-05-18
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