Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1474-2023 — SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200

U.S. FDA — Device Enforcement · United States · 2023-03-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1474-2023
Date of alert
2023-03-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327051650
Reported risk: Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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