SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832110TRecalls & reported problems
Sol-Millennium Medical, Inc. · Used to inject medicines and vaccines into, or withdraw fluids from the body. · Class 2
All models of SOL-M Luer Lock Syringe with Exchangeable Needle (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10818392012887), received between May 16, 2025 and Jun 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Decoupling” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 9, 2024Class IIOpen, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3075-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Decoupling2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THEY HAVE BEEN HAVING ISSUES WITH, BASICALLY, EVERY TRAY HAVING NEEDLES THAT AREN'T ATTACHED TO THE SYRINGES. IT'S PROBABLY ABOUT 80 TO 90 PERCENT OF EACH TRAY WHERE WE HAVE TO ATTACH THE NEEDLE TO THE SYRINGE BEFORE WE CAN DRAW OUR DOSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22291032 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
"CUSTOMER REPORTED: THE NEEDLES THAT ARE SUPPOSED TO BE CONNECTED TO THE SYRINGES ARE NOT IN MOST OF THE TRAYS THE CUSTOMER WOULD LIKE TO RETURN THE ITEM PO # (B)(4). SKU: 1832110T".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035565 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page