Sure Comfort 22-6505Recalls & reported problems
Allison Medical, Inc. · 0.5mL 31G 8mm Single use disposable insulin syringe with needle. Includes 100 sterile syringes in convenient 10 pack bags. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00786227650555), received between Dec 5, 2022 and May 15, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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
- Nonstandard Device1
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Nonstandard Device; Nonstandard Device
NEEDLE BOND FAILURE. THE NEEDLE IS PUSHED INSIDE THE SYRINGE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19323321 ↗InjuryDec 5, 2022Use of Device Problem; Use of Device Problem
PATIENT'S FATHER, STATES THAT THE SYR/NEEDLE COMBO THAT WE HAVE SENT WITH THE PATIENTS SALZEN (THE NEEDLE) HAS BROKEN 3X IN THE PATIENT'S LEG PER FATHER'S REQUEST, PLEASE DC ALL NDLS AND SYR FOR THE PT SALZEN DUE RPH.
Patient problems: Foreign Body In Patient
MAUDE report 15915337 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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