73 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code MSD·April 10, 2026
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
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code MMI·November 18, 2024
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·February 18, 2025
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0
FDA Recall
Open, Classified
·Advanced Instruments, LLC·Product code JJM·March 11, 2024
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
FDA Recall
Open, Classified
·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350
FDA Recall
Open, Classified
·Moberg Research, Inc.·Product code OMA·February 20, 2023
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
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
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
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
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
FDA Recall
Open, Classified
·GE Healthcare·Product code LLZ·August 5, 2024
Stryker MV3 bariatric bed, Part Number 5900000001
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code OSI·October 31, 2025
Stryker Arise 1000EX mattress, Part Number 2236000000
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code FNM·October 31, 2025
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
FDA Recall
Open, Classified
·Hologic, Inc·Product code KNW·January 15, 2025
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KDJ·February 1, 2023
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·May 21, 2024