Visionsense, Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0281-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

Product Classification:

Class II

Date Initiated: October 17, 2022

Date Posted: November 30, 2022

Recall Number: Z-0281-2023

Event ID: 91055

Reason for Recall:

XXX

Status: Ongoing

Product Quantity: 34 units: 15 units OUS; 19 units US

Code Information:

UDI-DI: 10813040013711 Lot Numbers: Serial Number/Lot Number 378-4005 378-4514 378-4516 378-4517 378-4518 378-4519 378-4520 378-4521 378-4522 378-4523 378-4525 378-4526 378-4527 378-4528 378-4534 378-4586 3784692 3784693 3784694 3784696 3784700 3784701 3784702 3784703 3784704 3784784 3784786 3784787 3784802 3784803 3784807 3784808 3784874 3784875

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated