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MEDLINE 402009RHRecalls & reported problems

Medline Industries, Inc. · SJM SUPREME CATH FIXED CRD2 6POLE 5MM 5F · Class 2

Data updated Oct 16, 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 16, 2026.

Recalls naming this device

  1. Dec 22, 2025Open, Classified

    These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

    Z-1322-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Other Catheter, recording, electrode, reprocessed devices

All Catheter, recording, electrode, reprocessed devices →

Sources and updates

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