Ultra-Fine 328290Recalls & reported problems
Embecta Medical II, LLC · Ultra-Fine™ Insulin Syringes, U-100, 8mm, 31G, 0.5mL · Class 2
Data updated Oct 16, 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 10383017829015), received between Jul 17, 2025 and Jul 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionJul 17, 2025Break; Break
CONSUMER REPORTED THE NEEDLE BROKE IN HER SITE AFTER INJECTION. WAS ABLE TO REMOVE ON HER OWN. NO MEDICAL ATTENTION NEEDED. DENIED REUSE OF NEEDLES. FEELS THE EMBECTA BRAND IS INFERIOR TO BD. INFORMED CALLER SEVERAL TIMES WE ARE THE SAME. SENDING MAILING KIT. LOT # 5042112. CATALOG# 328290 EMBECTA. DATE OF EVENT UNKNOWN LAST WEEK. SAMPLE STATUS AWAITING SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535700 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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