14 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Recall
Open, Classified
·Product code KIE·October 9, 2024
Atrium Pneumostat Chest Drain Valve, Part Number 16100
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code KDQ·August 26, 2021
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·April 6, 2021
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code KRA·November 6, 2023
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025
VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025
Alcohol (ALC) Test Saliva
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Recall
Open, Classified
·DRE Medical Group Inc·Product code MNT·May 15, 2023
Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·March 5, 2020
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·May 11, 2021
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
FDA Recall
Open, Classified
·Skytron, Div. The KMW Group, Inc·Product code FQO·June 2, 2022
3mensio Workstation (Vascular Fenestrated) software
FDA Recall
Open, Classified
·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025