The FDA announced on July 15, 2025, that Stryker Communications is recalling the Chromophare Surgical Light System and SLX to Oculan NFC Upgrade Kit due to powder coating stress lines. The agency stated the defect indicates potential chipping of the coating.
How to tell if you have it
- Brand: Stryker
- Product: Chromophare Surgical Light System, REF: CH00000001
- Product: SLX to Oculan NFC Upgrade Kit, REF: P60034
- 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
- Quantity: 40 units
- Distribution: US Nationwide in TX, IL, NY, UT, OR, AZ, VT, MN
The hazard
According to the FDA, surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Context
GovInfoNow's records show Stryker Communications has 9 other recalls on record since 2018-01-26. Other recent recalls of similar products include Stryker CHROMOPHARE Softlit Ring Surgical Light Recall (2026-02-23) and Stryker Chromophare Surgical Light System Recall (2024-02-08). Stryker S-Series Equipment Management System Recall occurred on 2021-01-29. Other recent recalls of similar products include Stryker XCEL Bladeless Trocar W/Stability Sleeve 5x75mm Recall (2026-08-19), Stryker XCEL Bladeless Trocar W/Stability Sleeve 12x100mm Recall (2026-08-19), and Stryker Hoffmann II Connecting Rod Micro 3 x 50mm (2026-07-01).