436 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FSY·November 8, 2023
AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code JKA·September 26, 2025
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
FDA Recall
Open, Classified
·Abbott·Product code OAE·March 24, 2022
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
FDA Recall
Open, Classified
·Abbott·Product code OAE·March 24, 2022
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
FDA Recall
Open, Classified
·Abbott·Product code OAE·June 9, 2022
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
FDA Recall
Open, Classified
·Abbott·Product code OAE·September 10, 2025
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OAE·October 10, 2024