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

Recall Z-0946-2025 — ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM

U.S. FDA — Device Enforcement · United States · 2024-12-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0946-2025
Date of alert
2024-12-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sklar Instruments
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50649111474796
Reported risk: Reports of various packaging issues that may result in a breach of the sterile barrier.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.