VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
Medical device recall Z-0280-2023. Published in FDA’s Enforcement Report on Nov 30, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 30, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 205 units: 94 units OUS; 111 units US how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
205 units: 94 units OUS; 111 units US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 18130400103489 Lot Numbes: 3784719 3784735 3784751 378-4001 378-4002 378-4003 378-4004 378-4006 378-4007 378-4008 378-4009 378-4010 378-4012 378-4013 378-4014 378-4015 378-4016 378-4017 378-4020 378-4021 378-4501 378-4502 378-4503…
Every code shown here, 1,736 characters
UDI-DI: 18130400103489 Lot Numbes: 3784719 3784735 3784751 378-4001 378-4002 378-4003 378-4004 378-4006 378-4007 378-4008 378-4009 378-4010 378-4012 378-4013 378-4014 378-4015 378-4016 378-4017 378-4020 378-4021 378-4501 378-4502 378-4503 378-4504 378-4505 378-4506 378-4507 378-4508 378-4510 378-4511 378-4512 378-4513 378-4515 378-4529 378-4531 378-4535 378-4537 3784581 378-4582 378-4583 378-4584 378-4588 378-4589 378-4590 3784592 378-4593 378-4594 3784595 378-4596 3784599 3784601 378-4602 3784603 378-4604 3784605 3784606 3784609 3784610 3784612 3784613 3784614 3784617 378-4618 3784619 3784620 3784621 3784622 3784623 3784624 3784626 3784627 3784628 3784629 3784632 3784633 3784635 3784636 3784637 3784638 3784641 3784644 3784645 3784646 3784648 3784649 3784650 3784651 3784652 3784653 3784654 3784656 378-4657 378-4658 3784659 3784660 3784661 3784662 3784663 3784664 3784665 3784666 3784667 3784669 3784671 3784672 3784674 378-4675 3784676 378-4677 3784679 3784680 3784681 3784682 3784683 3784685 3784686 3784687 3784688 3784689 3784691 3784705 3784706 3784708 3784713 3784715 3784716 3784717 3784718 3784720 3784721 3784723 3784725 3784726 3784727 3784728 378-4729 3784731 3784732 3784733 3784734 3784736 3784738 378-4739 378-4740 378-4742 3784743 3784744 378-4745 3784746 3784752 3784753 3784755 3784757 3784758 3784759 3784760 3784761 3784762 3784763 3784764 3784765 3784766 378-4767 378-4768 378-4769 3784775 3784776 3784777 3784779 3784780 3784781 3784789 3784790 3784791 3784792 3784793 3784798 3784799 3784801 378-4805 378-4806 3784809 3784811 3784812 3784813 3784819 3784821 3784822 3784824 3784825 3784826 3784827 3784828 378-4829 3784834 3784837 3784838 3784839 3784841 378-4858 3784863 3784864 3784865 3784867 3784868
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 17, 2022.
- FDA classified it on Nov 23, 2022.
- FDA’s Enforcement Report published it on Nov 30, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Visionsense, Ltd., of Petakh Tikva, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: N/A.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.