FDA Device recall Z-2620-2025
Chromophare Surgical Light System, REF: CH00000001
- FDA Device
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of Chromophare Surgical Light System, REF: CH00000001 by Stryker Communications, citing surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2620-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-15 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Communications |
| Distribution | US |
Product
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Reason
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Identifiers
| code_info | UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119…UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155. P60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2620-2025%22
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