Lower risk Medical device recall · FDA · Published February 27, 2026

Olympus SOLTIVE Laser System Recall: Potential 24V Power Supply Defect

Olympus recalls SOLTIVE Premium Laser Systems with TFL-PLS model containing TFL-CPLU component due to potential 24V power supply defect causing system inoperability or smoke/burning smell. Self-extinguishing if smoke occurs.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1694-2026Medical device Olympus ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling some SOLTIVE Premium Laser Systems (TFL-PLS model with TFL-CPLU component) because a potential defect in the 24V power supply may cause the system to stop working or produce smoke/burning smells. The smoke would be contained within the device and self-extinguish. Read more at govinfonow.com/recall/49880-olympus-soltive-laser-system-recall-potential-24v-power-supply-defect.

Source Summary by GovInfoNow · govinfonow.com/recall/49880-olympus-soltive-laser-system-recall-potential-24v-power-supply-defect · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1694-2026

Cite this page

“Olympus SOLTIVE Laser System Recall: Potential 24V Power Supply Defect.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49880-olympus-soltive-laser-system-recall-potential-24v-power-supply-defect. Based on FDA recall #Z-1694-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2026%22&limit=1).

The FDA announced on Feb. 27, 2026, that Olympus Corporation of the Americas is recalling SOLTIVE Premium SuperPulsed Laser Systems due to a potential defect in the 24V power supply module. The issue may cause the system to become inoperable or produce smoke and a burning smell.

How to tell if you have it

Brand: Olympus
Product Name: SOLTIVE Premium Laser System TFL-PLS
Model/Catalog Number: TFL-PLS containing TFL-CPLU
Serial #: MDUF220005 through MDUF240031 (specific list provided in record)
Units affected: 408

The hazard

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.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls of similar products include Repligen Maverick Measurement Module Spectrometer Recall: Laser Safety Risk (2025-12-10), Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients (2026-01-27), and Diowave Laser System Recall: Software Update Needed for Safety (2026-01-09).

How to tell if you have this one

Check for the SOLTIVE Premium Laser System TFL-PLS model with TFL-CPLU component. The device has specific serial numbers listed in the recall (e.g., MDUF220005, MDUF220005, etc.).

Brand
Olympus
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

Recall number	Product, codes & lots	Quantity
Z-1694-2026	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; 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, MDUF220348, MDUF220349, MDUF220350, MDUF220351, MDUF220358, MDUF220359, MDUF220360, MDUF220361, MDUF220362, MDUF220364, MDUF220365, MDUF220366, MDUF220367, MDUF220368, MDUF220370, MDUF220371, MDUF220373, MDUF220374, MDUF220375, MDUF220377, MDUF220378, MDUF220379, MDUF220380, MDUF220381, MDUF220382, MDUF220383, MDUF220384, MDUF220385, MDUF220388, MDUF220389, MDUF220391, MDUF220392, MDUF220394, MDUF220397, MDUF220399, MDUF220400, MDUF220402, MDUF220403, MDUF220404, MDUF220405, MDUF220406, MDUF220407, MDUF220408, MDUF220409, MDUF220410, MDUF220415, MDUF220416, MDUF220417, MDUF220418, MDUF220419, MDUF220420, MDUF220421, MDUF220423, MDUF220424, MDUF220425, MDUF220426, MDUF220428, MDUF220429, MDUF220431, MDUF220432, MDUF220433, MDUF220434, MDUF220435, MDUF220436, MDUF220438, MDUF220439, MDUF220440, MDUF220441, MDUF220442, MDUF220443, MDUF220444, MDUF220445, MDUF220448, MDUF220449, MDUF220450, MDUF220457, MDUF220458, MDUF220459, MDUF220460, MDUF220461, MDUF220462, MDUF220463, MDUF220464, MDUF220465, MDUF220466, MDUF220468, MDUF220469, MDUF220470, MDUF220471, MDUF220473, MDUF220476, MDUF220478, MDUF220481, MDUF220482, MDUF220483, MDUF220484, MDUF220485, MDUF220486, MDUF220488, MDUF220489, MDUF220492, MDUF220493, MDUF220494, MDUF220495, MDUF220496, MDUF220497, MDUF220498, MDUF220499, MDUF220500, MDUF220501, MDUF220502, MDUF220504, MDUF220505, MDUF220506, MDUF220507, MDUF220508, MDUF220509, MDUF220511, MDUF220512, MDUF220513, MDUF220515, MDUF220517, MDUF220518, MDUF220519, MDUF220520, MDUF220521, MDUF220523, MDUF220524, MDUF220525, MDUF220526, MDUF220527, MDUF220528, MDUF220530, MDUF220531, MDUF220532, MDUF220533, MDUF220534, MDUF220535, MDUF220536, MDUF220537, MDUF220538, MDUF220539, MDUF220541, MDUF220542, MDUF220543, MDUF220545, MDUF220546, MDUF220548, MDUF220550, MDUF220551, MDUF220552, MDUF220553, MDUF220554, MDUF220555, MDUF220556, MDUF220557, MDUF220558, MDUF220559, MDUF220560, MDUF220562, MDUF220563, MDUF220564, MDUF220565, MDUF220567, MDUF220568, MDUF220569, MDUF220570, MDUF220571, MDUF220572, MDUF220573, MDUF220574, MDUF220575, MDUF220576, MDUF220577, MDUF220578, MDUF220579, MDUF220580, MDUF220581, MDUF220582, MDUF220583, MDUF220584, MDUF220585, MDUF220586, MDUF220588, MDUF230002, MDUF230003, MDUF230008, MDUF230010, MDUF230011, MDUF230012, MDUF230014, MDUF230015, MDUF230016, MDUF230017, MDUF230019, MDUF230020, MDUF230021, MDUF230022, MDUF230023, MDUF230024, MDUF230025, MDUF230028, MDUF230030, MDUF230031, MDUF230032, MDUF230033, MDUF230034, MDUF230035, MDUF230036, MDUF230037, MDUF230038, MDUF230039, MDUF230040, MDUF230041, MDUF230042, MDUF230043, MDUF230044, MDUF230045, MDUF230046, MDUF230047, MDUF230048, MDUF230049, MDUF230050, MDUF230052, MDUF230053, MDUF230054, MDUF230055, MDUF230056, MDUF230057, MDUF230060, MDUF230061, MDUF230062, MDUF230064, MDUF230065, MDUF230067, MDUF230069, MDUF230070, MDUF230071, MDUF230072, MDUF230073, MDUF230074, MDUF230075, MDUF230077, MDUF230078, MDUF230079, MDUF230080, MDUF230081, MDUF230082, MDUF230084, MDUF230085, MDUF230086, MDUF230087, MDUF230088, MDUF230089, MDUF230090, MDUF230091, MDUF230092, MDUF230093, MDUF230094, MDUF230095, MDUF230096, MDUF230097, MDUF230098, MDUF230099, MDUF230102, MDUF230103, MDUF230104, MDUF230105, MDUF230106, MDUF230107, MDUF230108, MDUF230109, MDUF230110, MDUF230111, MDUF230112, MDUF230113, MDUF230114, MDUF230115, MDUF230116, MDUF230117, MDUF230118, MDUF230119, MDUF230120, MDUF230121, MDUF230122, MDUF230123, MDUF230124, MDUF230125, MDUF230126, MDUF230127, MDUF230128, MDUF230129, MDUF230130, MDUF230131, MDUF230132, MDUF230133, MDUF230134, MDUF230136, MDUF230137, MDUF230138, MDUF230139, MDUF230142, MDUF230143, MDUF230144, MDUF230145, MDUF230146, MDUF230147, MDUF230148, MDUF230149, MDUF230150, MDUF230151, MDUF230152, MDUF230153, MDUF230154, MDUF230156, MDUF230157, MDUF230158, MDUF230159, MDUF230160, MDUF230161, MDUF230162, MDUF230165, MDUF230168, MDUF230169, MDUF230170, MDUF230171, MDUF230172, MDUF230173, MDUF230174, MDUF230175, MDUF230176, MDUF230177, MDUF230178, MDUF230179, MDUF230180, MDUF230181, MDUF230182, MDUF230183, MDUF230184, MDUF230185, MDUF230186, MDUF230187, MDUF230188, MDUF230189, MDUF230190, MDUF230191, MDUF230192, MDUF230193, MDUF230194, MDUF230195, MDUF230196, MDUF230197, MDUF230198, MDUF230199, MDUF230200, MDUF230201, MDUF230202, MDUF230203, MDUF230204, MDUF230205, MDUF230206, MDUF230207, MDUF230208, MDUF230209, MDUF230210, MDUF230211, MDUF230212, MDUF230213, MDUF230214, MDUF230215, MDUF230216, MDUF230218, MDUF230219, MDUF230220, MDUF230221, MDUF230222, MDUF230223, MDUF230224, MDUF230226, MDUF230227, MDUF230228, MDUF230229, MDUF230230, MDUF230231, MDUF230232, MDUF230233, MDUF230235, MDUF230236, MDUF230237, MDUF230238, MDUF230239, MDUF230240, MDUF230241, MDUF230242, MDUF230243, MDUF230244, MDUF230245, MDUF230246, MDUF230247, MDUF230248, MDUF230249, MDUF230250, MDUF230251, MDUF230252, MDUF230253, MDUF230254, MDUF230255, MDUF230256, MDUF230257, MDUF230258, MDUF230259, MDUF230260, MDUF230261, MDUF230262, MDUF230263, MDUF230264, MDUF230265, MDUF230266, MDUF230267, MDUF230268, MDUF230269, MDUF230270, MDUF230272, MDUF230274, MDUF230275, MDUF230276, MDUF230277, MDUF230278, MDUF230279, MDUF230280, MDUF230281, MDUF230282, MDUF230286, MDUF230287, MDUF230288, MDUF230289, MDUF230290, MDUF230291, MDUF230292, MDUF230293, MDUF230294, MDUF230295, MDUF230296, MDUF230297, MDUF230298, MDUF230299, MDUF230300, MDUF230301, MDUF230302, MDUF230303, MDUF230304, MDUF230305, MDUF230306, MDUF230307, MDUF230308, MDUF230309, MDUF230310, MDUF230311, MDUF230314, MDUF230316, MDUF230317, MDUF230318, MDUF230319, MDUF230320, MDUF230321, MDUF230322, MDUF230324, MDUF230325, MDUF230326, MDUF230327, MDUF230328, MDUF230330, MDUF230333, MDUF230334, MDUF230335, MDUF230336, MDUF230337, MDUF230338, MDUF230339, MDUF230341, MDUF230342, MDUF230343, MDUF230344, MDUF230345, MDUF230346, MDUF230347, MDUF230348, MDUF230349, MDUF230350, MDUF230351, MDUF230352, MDUF230353, MDUF230354, MDUF230355, MDUF230356, MDUF230357, MDUF230358, MDUF230359, MDUF230360, MDUF230367, MDUF230368, MDUF230369, MDUF230370, MDUF230371, MDUF230372, MDUF230373, MDUF230374, MDUF230375, MDUF230376, MDUF230377, MDUF230379, MDUF230380, MDUF230381, MDUF230382, MDUF230383, MDUF230384, MDUF230385, MDUF230386, MDUF230387, MDUF230388, MDUF230389, MDUF230390, MDUF230391, MDUF230392, MDUF230393, MDUF230394, MDUF230395, MDUF230396, MDUF230397, MDUF230398, MDUF230399, MDUF230400, MDUF230401, MDUF230402, MDUF230404, MDUF230405, MDUF230406, MDUF230407, MDUF230408, MDUF230409, MDUF230410, MDUF230414, MDUF230417, MDUF230418, MDUF230419, MDUF230420, MDUF230421, MDUF230422, MDUF230423, MDUF230424, MDUF230425, MDUF230426, MDUF230427, MDUF230428, MDUF230429, MDUF230430, MDUF230431, MDUF230432, MDUF230433, MDUF230434, MDUF230435, MDUF230436, MDUF230437, MDUF230438, MDUF240001, MDUF240002, MDUF240003, MDUF240004, MDUF240005, MDUF240006, MDUF240007, MDUF240008, MDUF240009, MDUF240012, MDUF240013, MDUF240014, MDUF240015, MDUF240016, MDUF240017, MDUF240018, MDUF240019, MDUF240020, MDUF240021, MDUF240022, MDUF240024, MDUF240025, MDUF240026, MDUF240027, MDUF240028, MDUF240029, MDUF240030, MDUF240031;	408 units
Z-1695-2026	Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU 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; Laser System: TFL-SLS; UDI: 00821925044135; Component Part: TFL-CSLU; UDI: 00821925044593; Serial #: MDUF190114, MDUF220073, MDUF220331, MDUF220353, MDUF220354, MDUF220356, MDUF220411, MDUF220412, MDUF220413, MDUF220414, MDUF220427, MDUF220451, MDUF220453, MDUF220454, MDUF220455, MDUF220456, MDUF230004, MDUF230005, MDUF230006, MDUF230007, MDUF230076, MDUF230140, MDUF230141, MDUF230163, MDUF230164, MDUF230166, MDUF230167, MDUF230234, MDUF230283, MDUF230284, MDUF230331, MDUF230332, MDUF230361, MDUF230362, MDUF230363, MDUF230364, MDUF230365, MDUF230366, MDUF230411, MDUF230412, MDUF230413;	32 units

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Compare your device's serial number to the list of affected units provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Feb 27, 2026Firm started the recall
Mar 30, 2026FDA classified it Class II
Apr 8, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49880-olympus-soltive-laser-system-recall-potential-24v-power-supply-defect">Olympus SOLTIVE Laser System Recall: Potential 24V Power Supply Defect (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1694-2026 (February 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1694-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.