Medline Industries, Inc. STAPLER35WPBRecalls & reported problems
Medline Industries, Inc. · STAPLER 35 WIDE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884389030844), received between Aug 14, 2026 and Sep 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break3
- Explosion1
- Failure to Form Staple1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
It was reported that "Staples are breaking in half with during use."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896164 ↗MalfunctionSep 13, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747903 ↗MalfunctionSep 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747873 ↗MalfunctionAug 14, 2026Break; Explosion
It was reported that these staplers have been "exploding" or "breaking apart" when applied.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253257 ↗
Other STAPLER, SURGICAL devices
- ECHELON ECH60SEthicon Endo-Surgery, LLC · Stapler, surgical1 death631 reports
- ECHELON ECH60LEthicon Endo-Surgery, LLC · Stapler, surgical467 reports
- ECHELON ECH45SEthicon Endo-Surgery, LLC · Stapler, surgical269 reports
- EEA TRIEEA28XTCovidien LP · Stapler, surgical220 reports
- ECHELON ECH60CEthicon Endo-Surgery, LLC · Stapler, surgical197 reports
- ECHELON ECH45CEthicon Endo-Surgery, LLC · Stapler, surgical138 reports
- EEA TRIEEA31XTCovidien LP · Stapler, surgical73 reports
- ETHICON EC3D60LEthicon Endo-Surgery, LLC · Stapler, surgical39 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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