Chromophare Surgical Light System — Class II medical device recall Z-2620-2025
Ongoing recall by Stryker Communications, reported 2025-10-01, distributed nationwide. Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping
| Recall number | Z-2620-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Communications, Flower Mound, TX, United States |
| Recall initiated | 2025-07-15 |
| Classified | 2025-09-24 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| UPC / GTIN / UDI-DI | 07613327296167, 07613327651317 |
| Serial numbers | 1000016, 1000017, 1000018, 1000019, 1000020, 1000021, 1000023, 1000024, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010137, 7000010141, 7000010142, 7000010143, 7000010145, 7000010146, 7000010147, 7000010148 and 15 more |
| Model numbers | CH00000001, P60034 |
Product
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Reason for recall
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
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-2620-2025. 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.