Tranberg Laser Applicator Non-cooled — Class II medical device recall Z-1782-2021
Terminated recall by CLINICAL LASERTHERMIA SYSTEMS AB, reported 2021-06-09, distributed nationwide. single use devices labeled as sterile may not have been adequately sterilized
| Recall number | Z-1782-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CLINICAL LASERTHERMIA SYSTEMS AB, Lund, Sweden |
| Recall initiated | 2021-04-01 |
| Classified | 2021-06-03 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE |
| Quantity | 90 units |
| Reason classes | labeling, sterility |
| Lot numbers | 00029/2020/02, 00049/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00247/2019/11 |
| Model numbers | 4017-02 |
Product
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.
Reason for recall
single use devices labeled as sterile may not have been adequately sterilized
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-1782-2021. 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.