SafeLight Fiber Optic Cable Recall Due to Assembly Defect
Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy on the proximal end, which can cause light output failure and potentially delay surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. However, the defect creates a risk of harm by potentially causing surgical procedure delays or conversion to open procedures. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling SafeLight Fiber Optic Cables in two variants (Clear, REF 0233-050-100; Gray, REF 0233-050-200) due to a manufacturing defect. Approximately 5,228 units were assembled with insufficient epoxy on the proximal end.
The defect can cause light output issues during surgical use. This may result in clinical delay or require the surgical procedure to be converted to an open procedure rather than a minimally invasive approach.
The affected units have been distributed nationwide throughout the United States and internationally to multiple countries including the Netherlands, Peru, Austria, Canada, Taiwan, Philippines, Singapore, South Korea, and China. Specific lot numbers are identified in the FDA recall notice.
The recalled product
- Product
- SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
- Manufacturer
- Stryker Corporation
- Affected units
- 5,228
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)
- Ref/UDI-DI/Lot: 0233-050-100/07613327051650/159190
- 159191
- 159192
- 159194
- 159195
- 159196
- 159197
- 159198
- 159199
- 159200
- 159201
- 159202
- 159203
- 159204
- 159205
- 159206
- 159207
- 159208
- 159209
- 159210
Distribution
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