droplet® pen needles 32Gx6mmRecalls & reported problems
Htl Strefa S A · Sterile single use droplet® pen needles intended for use with pen injector devices for the subcutaneous injection of drugs. · Class 2
All models of droplet pen needles (9)
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 00857273002275), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
Patient problems
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2026Material Twisted/Bent
ON 01/07/2026 HTL-STREFA INC. RECEIVED A PHONE CALL COMPLAINT. CUSTOMER'S PEN NEEDLES ARE BENDING ON CONTACT WITH THE SKIN. HE REPORTED 2 PEN NEEDLES HAD 90-DEGREE ANGLE BENDS WHEN HE REMOVED THE PEN NEEDLE FOLLOWING INJECTION ATTEMPT. HE DID HAVE MIS DOSING FOLLOWING ONE INJECTION WHERE HIS LEVEL RECORDED A 315. HE WAS ABLE TO BALANCE HIS LEVELS AFTER EATING SOMETIME LATER. CUSTOMER DID NOT SUFFER ANY ADDITIONAL INJURIES OR HEALTH CONSEQUENCES. CUSTOMER USES FLEXPEN FOR HIS INJECTIONS. CUSTOMER CONFIRMED FOLLOWING THE IFU AND ROTATING INJECTION SITES. WE ARE SENDING REPLACEMENT SAMPLES AND CUSTOMER AGREED TO SUBMIT SAMPLES FOR INVESTIGATION ANALYSIS. SAMPLE FORM THE CUSTOMER HAS NOT BEEN RETURNED FOR FURTHER ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 24220933 ↗
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- 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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