DropSafe, safety pen needles 31G x 8mmRecalls & reported problems
Htl Strefa S A · 100 pcs sterile single use DropSafe pen needles per box, intended for use with pen injector devices for the injection of drugs. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05907996091591), received between May 26, 2025 and May 26, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (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.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Did Not Operate1
- Material Twisted/Bent1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2025Material Twisted/Bent; Fail-Safe Did Not Operate; Material Twisted/Bent; Fail-Safe Did Not Operate
ON 05/08/2025 HTL-STREFA INC. RECEIVED AN EMAIL COMPLAINT NOTIFICATION FROM (B)(6). CUSTOMER STATED: THE NEEDLE BENT THROUGH THE HOLE AND POKED A STAFF MEMBER. NO ADDITIONAL INFORMATION FOR COMPLAINT IS AVAILABLE AT TIME OF REGISTRATION. COMMUNICATION VIA EMAIL AND VOICEMAIL WAS SENT TO THE CUSTOMER FOR ADDITIONAL INFORMATION. WE ARE CURRENTLY WAITING FOR A RESPONSE. ADDITIONAL INFORMATION HAS BEEN PROVIDED TO THE COMPLAINT NOTIFICATION: WHETHER THE NURSE HAS ANY MEDICAL CONSEQUENCES RELATED TO THE INJURY? NO. WHETHER THE PATIENT AND NURSE WERE EXAMINED? YES, THE NURSE AND THE PATIENT WERE BOTH EXAMINED AT LOCAL URGENT CARE AND TEST RESULTS AS OF TODAY ARE NEGATIVE FOR BOTH NURSE AND PATIENT. ARE SAMPLES UNDER COMPLAINT AVAILABLE? YES, I EMAILED RETURN LABEL FOR SAMPLES TO THE CUSTOMER. SAMPLE UNDER COMPLAINT HAS NOT BEEN RETURNED TO HTL-STREFA UNTIL THIS REPORT.
Patient problems: Needle Stick/Puncture
MAUDE report 22084141 ↗
Other Needle, Hypodermic, Single Lumen devices
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- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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