Class II U.S. Food and Drug Administration

Brand Name: Olympus Soltive Premium SuperPulsed Laser System Product recall: Following a complaint investigation, Olympus identified a potential defect

Recall published 7 months ago

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

The hazard: Fire or burn hazard

The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

What the notice says: Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1694-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Olympus Corporation of the Americas
Product type
Medical devices
Units affected
408 units
Distribution
Nationwide
Made in
United States
Lot / code info
Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF220005, MDUF220005, MDUF220437, MDUF220437, MDUF220446, MDUF220446, MDUF190072, MDUF200324, MDUF210030, MDUF210204, MDUF210379, MDUF220001, MDUF220002, MDUF220003, MDUF220007, MDUF220008, MDUF220009, MDUF220010, MDUF220011, MDUF220012, MDUF220013, MDUF220014, MDUF220015, MDUF220016, MDUF220017, MDUF220018, MDUF220019, MDUF220020, MDUF220021, MDUF220022, MDUF220023, MDUF220024, MDUF220025, MDUF220026, MDUF220027, MDUF220028, MDUF220029, MDUF220030, MDUF220031, MDUF220032, MDUF220033, MDUF220034, MDUF220035, MDUF220036, MDUF220037, MDUF220038, MDUF220039, MDUF220040, MDUF220042, MDUF220043, MDUF220044, MDUF220045, MDUF220046, MDUF220047, MDUF220048, MDUF220049, MDUF220050, MDUF220051, MDUF220052, MDUF220053, MDUF220054, MDUF220055, MDUF220056, MDUF220057, MDUF220058, MDUF220060, MDUF220061, MDUF220062, MDUF220063, MDUF220064, MDUF220065, MDUF220066, MDUF220067, MDUF220069, MDUF220070, MDUF220071, MDUF220072, MDUF220074, MDUF220075, MDUF220076, MDUF220077, MDUF220078, MDUF220079, MDUF220080, MDUF220081, MDUF220082, MDUF220083, MDUF220084, MDUF220085, MDUF220086, MDUF220087, MDUF220088, MDUF220089, MDUF220090, MDUF220091, MDUF220092, MDUF220093, MDUF220094, MDUF220095, MDUF220096, MDUF220097, MDUF220098, MDUF220100, MDUF220101, MDUF220102, MDUF220103, MDUF220106, MDUF220109, MDUF220110, MDUF220111, MDUF220113, MDUF220114, MDUF220115, MDUF220116, MDUF220117, MDUF220119, MDUF220120, MDUF220123, MDUF220124, MDUF220126, MDUF220127, MDUF220128, MDUF220130, MDUF220131, MDUF220133, MDUF220135, MDUF220137, MDUF220138, MDUF220139, MDUF220140, MDUF220141, MDUF220142, MDUF220143, MDUF220144, MDUF220145, MDUF220146, MDUF220147, MDUF220149, MDUF220150, MDUF220151, MDUF220152, MDUF220153, MDUF220154, MDUF220155, MDUF220156, MDUF220157, MDUF220158, MDUF220159, MDUF220160, MDUF220161, MDUF220162, MDUF220163, MDUF220164, MDUF220165, MDUF220166, MDUF220167, MDUF220168, MDUF220170, MDUF220171, MDUF220172, MDUF220173, MDUF220174, MDUF220175, MDUF220176, MDUF220177, MDUF220178, MDUF220179, MDUF220180, MDUF220181, MDUF220182, MDUF220183, MDUF220184, MDUF220185, MDUF220186, MDUF220187, MDUF220188, MDUF220189, MDUF220190, MDUF220191, MDUF220192, MDUF220193, MDUF220194, MDUF220195, MDUF220196, MDUF220198, MDUF220199, MDUF220200, MDUF220201, MDUF220202, MDUF220203, MDUF220204, MDUF220205, MDUF220206, MDUF220207, MDUF220208, MDUF220209, MDUF220210, MDUF220211, MDUF220212, MDUF220213, MDUF220214, MDUF220216, MDUF220217, MDUF220218, MDUF220219, MDUF220220, MDUF220221, MDUF220222, MDUF220223, MDUF220224, MDUF220225, MDUF220226, MDUF220227, MDUF220228, MDUF220229, MDUF220230, MDUF220231, MDUF220232, MDUF220233, MDUF220234, MDUF220235, MDUF220237, MDUF220238, MDUF220240, MDUF220241, MDUF220242, MDUF220243, MDUF220244, MDUF220245, MDUF220246, MDUF220247, MDUF220248, MDUF220249, MDUF220250, MDUF220251, MDUF220252, MDUF220253, MDUF220254, MDUF220255, MDUF220256, MDUF220257, MDUF220258, MDUF220259, MDUF220260, MDUF220261, MDUF220262, MDUF220263, MDUF220264, MDUF220265, MDUF220266, MDUF220267, MDUF220268, MDUF220269, MDUF220270, MDUF220271, MDUF220272, MDUF220273, MDUF220274, MDUF220275, MDUF220276, MDUF220277, MDUF220278, MDUF220279, MDUF220280, MDUF220281, MDUF220283, MDUF220284, MDUF220285, MDUF220286, MDUF220287, MDUF220288, MDUF220289, MDUF220291, MDUF220292, MDUF220294, MDUF220295, MDUF220296, MDUF220297, MDUF220298, MDUF220299, MDUF220300, MDUF220301, MDUF220302, MDUF220303, MDUF220304, MDUF220305, MDUF220306, MDUF220307, MDUF220308, MDUF220309, MDUF220310, MDUF220311, MDUF220312, MDUF220313, MDUF220314, MDUF220315, MDUF220316, MDUF220317, MDUF220318, MDUF220320, MDUF220321, MDUF220322, MDUF220323, MDUF220324, MDUF220326, MDUF220327, MDUF220328, MDUF220329, MDUF220330, MDUF220332, MDUF220333, MDUF220334, MDUF220335, MDUF220336, MDUF220337, MDUF220338, MDUF220339, MDUF220340, MDUF220341, MDUF220342, MDUF220343, MDUF220344, MDUF220345, MDUF220346, MDUF220347…
UPC codes
00821925044111, 00821925044586

Products covered by this recall

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00821925044111
  • 00821925044586

Model or item number

On the rating label, the box or the instruction sheet.

  • TFL-CPLU

Serial number

On the rating plate, often next to the date of manufacture.

  • MDUF220005
  • MDUF220437
  • MDUF2

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Olympus Corporation of the Americas — The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  3. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  4. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Olympus Corporation of the Americas — 3500 Corporate Pkwy, Center Valley, PA, 18034-8229

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus Corporation of the Americas medical devices recalled?

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00821925044111, 00821925044586; model number TFL-CPLU. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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