Merit Medical Systems, Inc. recalls
11 recalls on record · FDA
Every recall we have on record for Merit Medical Systems, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C,…
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe,…
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX…
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, …
The sterility of microcatheter and infusion system devices cannot be guaranteed.