Class IIOngoingZ-1225-2026
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST150 SET US
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
VANTIVE US HEALTHCARE…ILFeb 11, 2026
Recalls: Component design/selection
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 87 recalls
Class IIOngoingZ-1224-2026
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 SET US
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
VANTIVE US HEALTHCARE…ILFeb 11, 2026
Class IIOngoingZ-1004-2026
Vortex Surgical Inc. recalls Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Vortex Surgical Inc.MOJan 7, 2026
Class IIOngoingZ-0917-2026
Datascope Corp. recalls Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Datascope Corp.NJDec 17, 2025
Class IIOngoingZ-0916-2026
Datascope Corp. recalls Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Datascope Corp.NJDec 17, 2025
Class IIOngoingZ-0879-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Fusion
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0878-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0877-2026
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Revelation
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Soluti…PADec 10, 2025
Class IIOngoingZ-0372-2026
ASP Global, LLC. Dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems.…
ASP Global, LLC. dba A…GANov 5, 2025
Class IIOngoingZ-2609-2025
Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Biofire DefenseUTOct 1, 2025
Class IOngoingZ-2567-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
MEDLINE INDUSTRIES, LP…ILOct 1, 2025
Class IOngoingZ-2566-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
MEDLINE INDUSTRIES, LP…ILOct 1, 2025