DropSafe Syringe with Safety Needle 25G x 3 mlRecalls & reported problems
Htl Strefa S A · The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration and injection of fluids for medical purpouse. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 05907996099214), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2021Leak/Splash
DROPSAFE 3ML SYRINGES BEING USED TO INJECT JANSSEN COVID-19 VACCINE TREATMENT UNDER EMERGENCY USE AUTHORIZATION (EUA): REPORTING THIS FOR DEVICE ONLY (SYRINGE/NEEDLE COMBINATION). SIMILAR REPORT WAS FILED FOR TWO SYRINGES OF THE SAME LOT THAT WERE DISCOVERED ON (B)(6) 2021 TO BE DEFECTIVE AND WERE REPORTED ON 4/08/2021. THIS IS FOR THREE ADDITIONAL SYRINGES THAT WERE PART OF THE SUPPLY TO BE USED AT A VACCINATION CLINIC ON (B)(6) 2021 BY (B)(6). PREVIOUSLY, WE HAD A SYRINGE/NEEDLE COMBINATION LEAK/COME APART WHILE IT WAS BEING INJECTED INTO A PATIENT THE PREVIOUS WEEK. A SEPARATE VAERS REPORT WAS FILED FOR THAT EVENT. WHEN SECURING THE NEEDLE TO THE SYRINGE, THE NEEDLE DOES NOT FIRMLY LOCK INTO PLACE AND CAN CONTINUE TO BE ROTATED WITHOUT THERE BEING A SECURE CONNECTION. WE HAVE PREVIOUSLY EXPERIENCED THIS MANY TIMES BEFORE AND HAVE DISCARDED MANY SYRINGES FROM THIS MANUFACTURER PRIOR TO USE (DIFFERENT LOTS/PRODUCTS) WITHOUT IT BEING REPORTED TO MEDWATCH. OTHER RELEVANT INFORMATION ON LABEL: (B)(4), LOT 0325250004 2025-12-01. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 11663651 ↗
Other Syringe, Antistick devices
- BD Integra 305270Becton, Dickinson And Company · SYRINGE, ANTISTICK261 reports
- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS101235FMedline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 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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