Sure Comfort 24-1215Recalls & reported problems
Allison Medical, Inc. · 31G x 5/16" (8mm) Single use disposable pen needle for use with most insulin delivery systems (Insulin Pen). Includes 100 sterile needles individually wrapped. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00786227121550), received between Apr 21, 2023 and Mar 15, 2024 — classified as 2 injuries, 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Manufacturing, Packaging or Shipping Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Administration Site Swelling1
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Material Fragmentation; Material Fragmentation
MR. (B)(6) (PT) SAYS TWO PEN NEEDLES GOT STUCK IN HIS SKIN. HE SUCCESSFULLY REMOVED THE NEEDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913494 ↗InjuryFeb 19, 2024Break; Break
PT (24 YO FEMALE) INJECTED INSULIN INTO HER STOMACH USING THE PEN NEEDLE. WHEN SHE REMOVED THE PEN, THE NEEDLE REMAINED INSIDE HER SKIN.
Patient problems: Foreign Body In Patient
MAUDE report 18731109 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT RECEIVED A NEW BRAND OF NEEDLES. NOW INJECTING NUTROPIN IS PAINFUL AND RESULTS IN A "BUBBLE" BELOW THE SKIN. INJECTION TECHNIQUE IS APPROPRIATE.
Patient problems: Administration Site Swelling
MAUDE report 16804799 ↗MalfunctionApr 21, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NEEDLES ARE BREAKING UPON INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790794 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- 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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