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

Recall Z-0308-2025 — DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06

U.S. FDA — Device Enforcement · United States · 2024-10-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0308-2025
Date of alert
2024-10-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
DeRoyal Industries Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00749756917292
Reported risk: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.