FDAMay 22, 2024device
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
What to do
FDA enforcement status: Ongoing
Brands named
merit medical systemsmeritmerit medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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
- 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
- CPSCGenerac Power Systems Expands Recall of Generac and DR Power Electric Start Pressure Washers Due to Risk of Serious Injury or Death from Carbon Monoxide Hazard; Includes Additional Models2026-05-14
- FDANicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.2026-05-14
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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