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Medline Industries, Inc. DYNJ53947JRecalls & reported problems

Medline Industries, Inc. · CARDIAC CATH IMF 86040- LF · 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. Mar 24, 2026Open, Classified

    Medline has identified the presence of particulate within the fluid path of the Manifolds.

    Z-2144-2026 · Root cause: Under Investigation by firm · FDA record ↗

  2. Feb 25, 2026Open, Classified

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Z-1835-2026 · 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.