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

Recall Z-0511-2026 — MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M

U.S. FDA — Device Enforcement · United States · 2025-09-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0511-2026
Date of alert
2025-09-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10195327384371
Reported risk: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain 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.