Sure Comfort 22-6503Recalls & reported problems
Allison Medical, Inc. · 0.3mL 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 00786227650357), received between Oct 26, 2018 and Dec 5, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
I AM AN INSULIN DEPENDENT DIABETIC. I GOT A NEW BOX OF SYRINGES FROM MY PHARMACY, AS I HAD USED UP THE LAST BOX. I AM HAVING A VERY HARD TIME REMOVING THE CAPS ON THIS LOT OF SYRINGES. MY DAUGHTER (WHO IS AN EMT) IS ALSO HAVING GREAT DIFFICULTY REMOVING THE CAPS SO MUCH FORCE IS NEEDED. I HAVE STUCK MY FINGER A FEW TIMES TRYING TO REMOVE THE CAP.
Patient problems: Needle Stick/Puncture
MAUDE report 15915929 ↗MalfunctionOct 26, 2018Difficult to Remove
I AM AN INSULIN DEPENDENT DIABETIC. I GOT A NEW BOX OF SYRINGES FROM MY PHARMACY, AS I HAD USED UP THE LAST BOX. I AM HAVING A VERY HARD TIME REMOVING THE CAPS ON THIS LOT OF SYRINGES. MY DAUGHTER (WHO IS AN EMT) IS ALSO HAVING GREAT DIFFICULTY REMOVING THE CAPS. SO MUCH FORCE IS NEEDED, I HAVE STUCK MY FINGER A FEW TIMES TRYING TO REMOVE THE CAP.
Patient problems: Needle Stick/Puncture
MAUDE report 8014248 ↗
Other Syringe, Piston devices
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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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