Sure Comfort 22-6510Recalls & reported problems
Allison Medical, Inc. · 1mL 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00786227651057), received between Nov 30, 2022 and Nov 30, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2022Use of Device Problem; Use of Device Problem
PATIENT USING INSULIN SYRINGE FOR ED INJECTIONS. THE NEEDLE BROKE AT THE INTERFACE BETWEEN THE CANNULA AND SYRINGE BARREL DURING AN INJECTION, LEAVING THE CANNULA INSIDE HIS BODY.
Patient problems: Foreign Body In Patient
MAUDE report 15890043 ↗InjuryNov 30, 2022Use of Device Problem; Use of Device Problem
PATIENT USING AN INSULIN SYRINGE FOR ED INJECTIONS (NOT INDICATED, BUT PRESCRIBED BY A PHYSICIAN). ABOUT HALF OF THE NEEDLE BROKE OFF DURING THE INJECTION INTO THE SKIN.
Patient problems: Foreign Body In Patient
MAUDE report 15889898 ↗
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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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