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Paradise® Catheter PRDS-068-02Recalls & reported problems

Recor Medical, Inc. · PRDS-068-02 Paradise® Catheter 8mm · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Jan 29, 2026Class IIOpen, Classified

    Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

    Z-1654-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Jan 29, 2026Class IIOpen, Classified

    Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

    Z-1655-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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Sources and updates

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