FDAClass IIJuly 1, 2026

Thuvera Laser Console. Software Version 2.2. Portable recall: Software Issue

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Why was Thuvera Laser Console. Software Version 2.2. Portable recalled?

Software anomaly that causes a false display of error code 5018.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. MD2300F-001507; UDI-DI 00810071230226; Serial No. MDUF250342, MDUF250400, MDUF250429, MDUF250060, MDUF250061, MDUF250067, MDUF250068, MDUF250069, MDUF250071, MDUF250076, MDUF250083, MDUF250086, MDUF250091, MDUF250092, MDUF250104, MDUF250131, MDUF250133, MDUF250134, MDUF250159, MDUF250160, MDUF250199, MDUF250200, MDUF250202, MDUF250203, MDUF250204, MDUF250205, MDUF250240, MDUF250241, MDUF250242, MDUF250278, MDUF250297, MDUF250299, MDUF250312, MDUF250314, MDUF250325, MDUF250340, MDUF250341, MDUF250351, MDUF250352, MDUF250355, MDUF250367, MDUF250368, MDUF250370, MDUF250380, MDUF250384, MDUF250385, MDUF250395, MDUF250399, MDUF250409, MDUF250410, MDUF250427, MDUF250430, MDUF250431, MDUF250433, MDUF260009, MDUF260010, MDUF260011, MDUF260017, MDUF260019, MDUF260023, MDUF260024, MDUF260025, MDUF260026, MDUF260027, MDUF260032, MDUF260043, MDUF260067, MDUF260068, MDUF260070, MDUF260072, MDUF260077, MDUF260079, MDUF260094, MDUF260095, MDUF260096, MDUF260097, MDUF260098, MDUF260099, MDUF260100, MDUF260101, MDUF260103, MDUF260104, MDUF260105, MDUF260106, MDUF260107, MDUF260108, MDUF260109, MDUF260112, MDUF260115, MDUF250014, MDUF250015, MDUF250016, MDUF250050, MDUF250051, MDUF250052, MDUF250053, MDUF250054, MDUF250055, MDUF250056, MDUF250057, MDUF250058, MDUF250059, MDUF250062, MDUF250063, MDUF250064, MDUF250065, MDUF250066, MDUF250070, MDUF250072, MDUF250073, MDUF250074, MDUF250075, MDUF250084, MDUF250085, MDUF250088, MDUF250089, MDUF250090, MDUF250093, MDUF250102, MDUF250103, MDUF250105, MDUF250132, MDUF250145, MDUF250158, MDUF250161, MDUF250162, MDUF250198, MDUF250201, MDUF250206, MDUF250207, MDUF250220, MDUF250237, MDUF250238, MDUF250239, MDUF250243, MDUF250245, MDUF250279, MDUF250280, MDUF250295, MDUF250296, MDUF250298, MDUF250310, MDUF250311, MDUF250313, MDUF250323, MDUF250344, MDUF250348, MDUF250349, MDUF250350, MDUF250353, MDUF250357, MDUF250364, MDUF250365, MDUF250369, MDUF250371, MDUF250372, MDUF250378, MDUF250379, MDUF250381, MDUF250382, MDUF250383, MDUF250386, MDUF250393, MDUF250396, MDUF250397, MDUF250398, MDUF250407, MDUF250408, MDUF250411, MDUF250412, MDUF250428, MDUF250432, MDUF260016, MDUF260018, MDUF260020, MDUF260031, MDUF260041, MDUF260044, MDUF260069, MDUF260071, MDUF260078, MDUF260088, MDUF260089, MDUF260090, MDUF260091, MDUF260092, MDUF260093, MDUF250087, MDUF250208, MDUF250244, MDUF250324, MDUF250326, MDUF250354, MDUF250356, MDUF250394, MDUF260042, MDUF260045, MDUF260076; Software Version 2.2.

Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Recalling firm
IPG Medical Corporation
Quantity
198 units
Distribution
US Nationwide distribution in the state of MA.
Recall date
July 1, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls