Recall of Olympus SOLTIVE Pro Laser System Due to Power Supply Defect
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Olympus Corporation of the Americas is recalling 32 units of the SOLTIVE Pro Laser System due to a potential defect in the power supply that could make the device inoperable and produce smoke or a burning smell.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
Recall of Olympus SOLTIVE Pro Laser System
What Happened
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, but by design, it is contained within the internal laser console enclosure and self-extinguishing.
Which Products Are Affected
The affected products are the Olympus SOLTIVE Pro SuperPulsed Laser System, specifically Model/Catalog Number: TFL-SLS containing TFL-CSLU. There are 32 units impacted, with UDI for the system: 00821925044135 and for the component: 00821925044593. The serial numbers include: 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. Distribution is nationwide in the US and also includes Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
What You Should Do
The recalling firm, Olympus Corporation of the Americas, has initiated this voluntary recall. Consumers with affected units should contact the firm for further instructions, using the provided recall information.
Why This Matters
This recall involves medical devices used for tissue ablation, and a potential failure could disrupt procedures, posing risks to patient safety due to device inoperability.
Source
FDA Recall Number: Z-1695-2026. For more information, refer to the FDA website at https://www.fda.gov/ (attribution: FDA event ID 98422).
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,889 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.