FDA Device recall Z-1694-2026
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-P…
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-P… by Olympus, citing 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 inoperab….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1694-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Olympus |
| Distribution | US |
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
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.
Identifiers
| code_info | Laser system: TFL-PLS; UDI: 00821925044111; Component Part: TFL-CPLU; UDI: 00821925044586; Serial #: MDUF…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, MDUF22006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2026%22
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