Chromophare Surgical Light Systems recalled for powder coating stress and chipping
Stryker Communications is recalling Chromophare Surgical Light Systems due to stress lines in the powder coating that may cause chipping. 40 units were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported incidents, illnesses, or injuries. The hazard—powder coating chipping—is a manufacturing defect with no documented safety consequences.
Plain-English summary
Stryker Communications is recalling the Chromophare Surgical Light System and SLX to Oculan NFC Upgrade Kit due to a manufacturing defect in the powder coating. The recall affects 40 units distributed in Texas, Illinois, New York, Utah, Oregon, Arizona, and Vermont.
The affected surgical lights exhibit stress lines in the powder coating that indicate chipping can occur. The FDA classified this as a Class II medical device recall.
Healthcare facilities should verify whether their equipment is affected by checking serial numbers against the recall list. Facilities with affected units should contact Stryker Communications for replacement or repair instructions.
The recalled product
- Product
- Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
- Manufacturer
- Stryker Communications
- Hazard
- powder-coating-failure
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 7000010117
- 7000010118
- 7000010119
- 7000010120
- 7000010121
- 7000010122
- 7000010123
- 7000010124
- 7000010125
- 7000010141
- 7000010142
- 7000010177
- 7000010178
- 7000010148
- 7000010149
- 7000010157
- 7000010137
- 7000010175
- 7000010176
- 7000010145
Distribution
Distributed nationwide across the United States.
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