Nano 2nd Gen 320550Recalls & reported problems
Embecta Medical II, LLC · Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00383017055035), received between Aug 25, 2025 and Sep 21, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (2 reports).
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
- Off-Label Use2
- Break1
- Failure to Deliver1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847662 ↗MalfunctionSep 2, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED. THAT THE NEEDLES ARE NOT SCREWING CORRECTLY INTO THE INSULYN PEN, AND ALSO WHEN CONSUMER IS USING, NEEDLES ARE GETTING CLOGGED, CONSUMER IS NOT PRIMING, ADVISE TO PRIME BEFORE USING. LOT #43033035. CATALOG# 320550. SAMPLE STATUS. NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22947647 ↗MalfunctionAug 25, 2025Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use
THE CONSUMER REPORTED "LEAKAGE" WHEN TAKING HER INJECTIONS. STATED, SOMETIMES THE MEDICATION WILL RUN DOWN HER STOMACH STATED, WHEN SHE ATTACHES HER PEN NEEDLES TO THE PEN, SHE WILL SEE "LEAKAGE" AROUND THE HUB. STATED, SHE DOES NOT PRIME BEFORE INJECTIONS. LOT: 4303034 CATALOG: 320550 DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891188 ↗
Other Needle, hypodermic, single lumen devices
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- 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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