143 results
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18ms
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Sources: EU EUDAMED, US FDA
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Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code MOS·April 19, 2010
EOS, Digital radiography system used in general radiographic examinations.
FDA Recall
Terminated
·Eos Imaging Inc·Product code MQB·February 17, 2015
ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·May 20, 2014
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code IEO·August 5, 2015
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
FDA Recall
Open, Classified
·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·November 20, 2023
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FEO·April 23, 2020
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·January 8, 2026
Clinical Chemistry Phosphorus assay
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CEO·May 4, 2010
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20
FDA Recall
Terminated
·Abbott Laboratories Inc.·Product code CEO·January 30, 2007
ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code IEO·March 30, 2012
Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
FDA Recall
Terminated
·Alfa Wassermann, Inc.·Product code CEO·October 10, 2012
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code IEO·November 13, 2012
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·July 7, 2022
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
FDA Recall
Open, Classified
·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025
ThermoFisher Scientific Microm STP 420D automated tissue processor.
FDA Recall
Terminated
·Thermo Fisher Scientific·Product code IEO·June 3, 2009
ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code CEO·April 24, 2025
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FEO·November 14, 2025