The FDA announced on March 2, 2023, that Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy causing light output issues. Owners should contact the company for a replacement.
How to tell if you have it
- Brand: Stryker
- Product: SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100
- Product: SafeLight Fiber Optic Cable: Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
- Lot codes for REF 0233-050-100: 159190 through 159218, 164764 through 164822, 168940 through 168981, 168987
- Lot codes for REF 0233-050-200: 158865, 158868, 158869, 158872, 158874, 158875, 158878, 158884, 165446, 165448, 165451, 165457 through 165459, 165461, 165462, 165464, 168909 through 168921, 168923 through 168928
- Units affected: 5,228
The hazard
The fiber optic cables were assembled with not enough epoxy on the proximal end, creating light output issues. This defect could cause a clinical delay or procedure being converted to open.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since 2017-11-17. Other recent recalls of similar products include Stryker Ahto Dual Spike Tube Set Leaks During Use (2026-06-08), Stryker Neptune Smart Docking Station Recall: Electrical Shock Risk (2026-05-06), and Stryker FluidSmart Urology Tube Set Recall: Nonconforming Products Distributed (2026-04-09). Other recent recalls of similar products include Stryker CHROMOPHARE Softlit Ring Surgical Light Recall: Ceiling Support Risk (2026-02-23), Beaver-Visitec OME6000U Laser System Recall: USB Cable Manufacturing Issue (2025-12-05), and Philips Azurion System Recall: Cable Hose Carriers May Loosen Over Time (2026-03-31).