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Truform® 0865-MRecalls & reported problems

Surgical Appliance Industries, Inc. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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.

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. Oct 7, 2011Terminated

    During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s

    Z-0391-2012 · Root cause: Employee error · FDA record ↗

Other Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) devices

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Sources and updates

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