Merit Medical® 00884450160596Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 19, 2024Class IIOpen, Classified

   Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

   Z-0070-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

2. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2562-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗