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Merit Medical® 00884450140840Recalls & reported problems

Merit Medical Systems, Inc. · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 30, 2024Open, Classified

    Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

    Z-0062-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

  2. Jun 11, 2024Open, 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-2579-2024 · Root cause: No Marketing Application · FDA record ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.