BERKELEY SAFE-TOUCH 003853-902Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821925037861), received between May 23, 2025 and Apr 24, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K171440); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE BERKELEY SAFE TOUCH HAD GREEN, STICKY RESIDUE AND BLACK MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988465 ↗
• MalfunctionApr 24, 2026Device Contaminated During Manufacture or Shipping

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BERKELEY SAFE TOUCH TISSUE TRAPS EXHIBITED GREEN, STICKY RESIDUE AND BLACK MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988291 ↗
• MalfunctionApr 24, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE BERKELEY SAFE TOUCH HAD GREEN, STICKY RESIDUE AND BLACK MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987850 ↗
• MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS SPOTTED. THE ISSUE WAS IDENTIFIED WHEN TAKEN OUT OF THE BOX. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091809 ↗
• MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BEEN SPOTTED AND IT WAS NOT USEABLE. THE ISSUE WAS IDENTIFIED UPON RECEIPT OR UNPACKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091797 ↗
• MalfunctionMay 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A SPOTTED, THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077765 ↗
• MalfunctionMay 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A SPOTTED, THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077686 ↗
• MalfunctionMay 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A SPOTTED, THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171440. One submission often covers many models, so check the product and lot details in each record.

• Z-0078-2023 · Sep 16, 2022 · Open, Classified
  Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.