Merit Medical ProGuide 16F Dialysis Sheath Introducer Recalled Worldwide in 2026 (131 Units)

How to identify if yours is affected

1. Review device packaging for model numbers and lot/UDI codes listed in the recall.
2. Compare your stock against the recall identifiers to identify affected devices.
3. Verify recall status with your procurement or supplier.

Where to find product info

Identifiers are printed on the device packaging and labeling. The FDA recall page provides the official list of identifiers.

What timeline to expect

Refunds or replacements are typically processed within weeks after verification and approval by the manufacturer.

If the manufacturer is unresponsive

• Escalate to hospital risk management or procurement, and contact the FDA/CPSc if needed
• Document all communication and attempts to resolve the issue.

How to prevent similar issues

• Institute a recall-check protocol for all dialysis-related devices
• Verify UDI and lot codes before use or placement
• Rely on official manufacturer and FDA recall notices for any future actions

Documentation advice

Retain recall notice, purchase records, packaging, serial/lot numbers, and correspondence with Merit Medical or suppliers.