Integra® Miltex® 33-100Recalls & reported problems
Integra Lifesciences Production Corporation · Integra® Miltex® Biopblade - Shave Biopsy Blade · Class 1
All models of Integra Miltex (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780064312), received between Jan 10, 2024 and Dec 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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.
Reports received per month
Most reported problems
Device problems
- Nonstandard Device1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Laceration(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Nonstandard Device; Nonstandard Device
InjuryJan 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
Other SCALPEL, ONE-PIECE devices
- AESCULAP BA823SUAesculap AG · SCALPEL, ONE-PIECE7 reports
- NA 232110Medos International Sàrl · SCALPEL, ONE-PIECE5 reports
- Kendall 139093Cardinal Health, Inc. · SCALPEL, ONE-PIECE2 reports
- Swann Morton Ltd. No. 11 BULK NON STERILE RETRACTABLE SCALPELSSwann-Morton Limited · Scalpel, One-Piece1 report
- Kendall 139090Cardinal Health, Inc. · SCALPEL, ONE-PIECE1 report
- DeRoyal D4511NS-500Deroyal Industries, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372615Aspen Surgical Products, Inc. · SCALPEL, ONE-PIECE1 report
- Bard-Parker ® Safety Scalped 372621Aspen Surgical Products, Inc. · SCALPEL, ONE-PIECE1 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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