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MEDLINE INDUSTRIES, INC. DYNJ55974DRecalls & reported problems

Medline Industries, Inc. · DR STEVENS OPEN HEART ADD ON · Class 2

Data updated Oct 21, 2026 from official FDA records · Editorial policy

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 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 21, 2026.

Recalls naming this device

  1. Sep 2, 2026Open, Classified

    Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

    Z-0176-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page