Stryker Communications — Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
⚠️ Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 15, 2025
US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
What's affected?
- Product
- Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
- Lot code
- 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
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 40.
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