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DropSafe Syringe 1mlRecalls & reported problems

Htl Strefa S A · The DropSafe Syringe is intended for use in the aspiration and injection of fluids for medical purpose. · Class 2

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 85907996099333), received between Mar 9, 2022 and Mar 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Microbial Contamination of 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Microbial Contamination of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 9, 2022Microbial Contamination of Device; Microbial Contamination of Device

    CUSTOMER REPORTED THAT ON (B)(6) 2022, UPON INSPECTING THE SYRINGES, MOLD AND CONDENSATION WERE DISCOVERED INSIDE THE SEALED, PACKAGED SYRINGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13714658 ↗

Other Syringe, Antistick devices

All Syringe, Antistick devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.