FDA Medical Device Recalls

Open, ClassifiedPosted Oct 30, 2025·Initiated Oct 1, 2025

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Reason: The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

Root cause: Nonconforming Material/Component

Recalling firm: Microgenics CorporationType: Multi-Analyte Controls, All Kinds (Assayed)Distribution: Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.Recall #Z-0415-2026

Open, ClassifiedPosted Oct 29, 2025·Initiated Aug 28, 2025

Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

Reason: Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Root cause: Software design

Recalling firm: Vantive US Healthcare LLCType: System, Peritoneal, Automatic DeliveryDistribution: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia.Recall #Z-0409-2026

Open, ClassifiedPosted Oct 29, 2025·Initiated Sep 26, 2025

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

Reason: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

Root cause: Process control

Recalling firm: Medistim AsaType: Flowmeter, Blood, CardiovascularDistribution: Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.Recall #Z-0410-2026

Open, ClassifiedPosted Oct 29, 2025·Initiated Aug 20, 2025

MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01

Reason: An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation

Root cause: Material/Component Contamination

Recalling firm: MicroSurgical Technology IncType: Knife, OphthalmicDistribution: US Nationwide distribution in the state of GA.Recall #Z-0411-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Sep 30, 2025

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Root cause: Under Investigation by firm

Recalling firm: IMPRIS Imaging IncType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.Recall #Z-0161-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Sep 30, 2025

IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Root cause: Under Investigation by firm

Recalling firm: IMPRIS Imaging IncType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.Recall #Z-0162-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Sep 30, 2025

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Root cause: Under Investigation by firm

Recalling firm: IMPRIS Imaging IncType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.Recall #Z-0163-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Sep 30, 2025

IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

Reason: There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Root cause: Under Investigation by firm

Recalling firm: IMPRIS Imaging IncType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.Recall #Z-0164-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Sep 3, 2025

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Reason: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Root cause: Process change control

Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US Nationwide distribution in the state of Minnesota.Recall #Z-0378-2026

Open, ClassifiedPosted Oct 28, 2025·Initiated Feb 17, 2025