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MEDLINE DYND13516Recalls & reported problems

Medline Industries, Inc. · CATHETER,URETHRAL,REDRUBBER,STRL,16FR · Class 2

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

Recalls naming this device

  1. May 4, 2026Open, Classified

    During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

    Z-2479-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Other CATHETER, URETERAL, GASTRO-UROLOGY devices

All CATHETER, URETERAL, GASTRO-UROLOGY devices →

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