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REFLEX 8535Recalls & reported problems

Conmed Corporation · Reflex One, Skin Stapler, 35 wide · Class 1

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20653405036958), received between Jan 4, 2017 and Jan 4, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

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.

Most reported problems

Device problems

  • Unsealed Device Packaging1

Patient problems

  • Not Applicable1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 4, 2017Unsealed Device Packaging; Unsealed Device Packaging

    THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 1 PACKAGE CONTAINING A REFLEX SKIN STAPLER 35 WIDE, WAS DISCOVERED TO HAVE "POOR SEALING." THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL INJURY WITH RECURRENCE.

    Patient problems: Not Applicable

    MAUDE report 6223014 ↗

Other CLIP, REMOVABLE (SKIN) devices

All CLIP, REMOVABLE (SKIN) devices →

Sources and updates

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