DeRoyal 25-3001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00749756024372), received between Sep 30, 2020 and Dec 23, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A USER FACILITY REPORTED, "PATIENT REPORTED WOUND HEALING ISSUES AT THE STAPLE SITE AND HAIR LOSS ALLEGEDLY CAUSED BY THE STAPLER."

  Patient problems: Hair Loss; Rash; Skin Inflammation/ Irritation

  MAUDE report 23876852 ↗
• InjuryAug 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001."

  Patient problems: Hair Loss

  MAUDE report 19951737 ↗
• InjuryAug 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001."

  Patient problems: Hair Loss

  MAUDE report 19951734 ↗
• InjuryAug 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001."

  Patient problems: Hair Loss

  MAUDE report 19951732 ↗
• InjuryAug 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A USER FACILITY REPORTED, "HELLO - I WOULD LIKE TO REPORT A QUALITY ISSUE WITH A DEROYAL PRODUCT. I RECENTLY SWITCHED PRODUCTS TO DEROYAL FOR STAPLES IN THE SCALP DURING SURGERY. I HAVE NOW HAD FOUR INSTANCES OF A SEVERE ALOPECIA AREATA OR INFLAMMATORY ALOPECIA LIKE REACTION AROUND THE STAPLES WHICH I HAVE NEVER SEEN BEFORE WITH ANY STAPLES. THEY ALL APPEAR TO BE FROM THE SAME LOT NUMBER AND TIME FRAME. ALL I CAN THINK OF IS THAT PERHAPS THERE IS SOMETHING IN THE COATING OF THE STAPLES. THE LOT NUMBER IS 73B2300556. REF 25-3001."

  Patient problems: Hair Loss

  MAUDE report 19951731 ↗
• MalfunctionSep 30, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  WHILE USING THE STAPLER TO CLOSE THE PATIENT'S SURGICAL INCISION, MULTIPLE STAPLES FELL OUT OF THE STAPLE GUN ONTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10608613 ↗