REFLEX 8035Recalls & reported problems
Conmed Corporation · Reflex One, Skin Stapler, 35 regular · Class 1
Data updated Oct 16, 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 20653405036927), received between Jul 7, 2020 and Jul 7, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Form Staple” (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 16, 2026.
Most reported problems
Device problems
- Failure to Form Staple1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2020Failure to Form Staple
SKIN STAPLER MALFUNCTIONED. TRIGGER WAS PULLED ONCE AND TWO STAPLES CAME OUT. THE FIRST ONE EMBEDDED INTO THE SKIN PROPERLY, AND THE SECOND ONE WENT IN ON ONE SIDE ONLY. FDA SAFETY REPORT ID #: (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10244956 ↗
Other CLIP, REMOVABLE (SKIN) devices
- REFLEX 8735Conmed Corporation · CLIP, REMOVABLE (SKIN)3 reports
- REFLEX 3013Conmed Corporation · CLIP, REMOVABLE (SKIN)3 reports
- REFLEX 8535Conmed Corporation · CLIP, REMOVABLE (SKIN)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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