Olympus Corporation of the Americas: 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

Recall number

Z-1694-2026

Recalling firm

Olympus Corporation of the Americas

Product

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

Status

Open, Classified

Initiated

2026-02-27

Posted

2026-03-30

Terminated

not on file

Reason

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.

Root cause

Process control

Action

On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the replacement of the 24V module in this corrective action will follow the standard SOLTIVE Laser repair process and your service contract, if applicable. 4. If you have further distributed the affected products, please forward this notice to other users who may be impacted.

Quantity

408 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

Lot, serial or model codes

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;

510(k) numbers

["K242191"]

PMA numbers

not on file

Product code

GEX

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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