Power Over Fiber Base Module — Class II medical device recall Z-2745-2026
Ongoing recall by Terex Utilities, reported 2026-08-05, distributed nationwide. Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorr
| Recall number | Z-2745-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Terex Utilities, Watertown, SD, United States |
| Recall initiated | 2026-05-11 |
| Classified | 2026-07-30 |
| Reported by FDA | 2026-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 101 |
| Reason classes | labeling |
Product
Power Over Fiber Base Module
Reason for recall
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement
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-2745-2026. 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.