Thuvera Laser Console — Class II medical device recall Z-2554-2026
Ongoing recall by IPG Medical Corporation, reported 2026-07-01, distributed nationwide. Software anomaly that causes a false display of error code 5018.
| Recall number | Z-2554-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IPG Medical Corporation, Marlborough, MA, United States |
| Recall initiated | 2026-05-05 |
| Classified | 2026-06-24 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 198 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00810071230226 |
| Serial numbers | MDUF250014, MDUF250015, MDUF250016, MDUF250050, MDUF250051, MDUF250052, MDUF250053, MDUF250054, MDUF250055, MDUF250056, MDUF250057, MDUF250058, MDUF250059, MDUF250060, MDUF250061, MDUF250062, MDUF250063, MDUF250064, MDUF250065, MDUF250066, MDUF250067, MDUF250068, MDUF250069, MDUF250070, MDUF250071 and 173 more |
| Model numbers | MD2300F-001507 |
Product
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Reason for recall
Software anomaly that causes a false display of error code 5018.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2554-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.