Halyard SAMM064-27_0002Recalls & 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 16, 2026.

Recalls naming this device

1. Aug 10, 2026Open, Classified

   Product may be potentially contaminated with a lubricant used during the manufacturing process.

   Z-0092-2027 · Root cause: Process change control · Recall details · FDA record ↗

2. Jul 9, 2026Open, Classified

   Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

   Z-3005-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗