SOL-M Syringe P180060Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-M 60ml Luer Lock Syringe w/o Needle · Class 2
All models of SOL-M Syringe (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818392018264), received between May 16, 2025 and Mar 5, 2026 — classified as 3 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
- Break1
- Contamination1
- Crack1
- Difficult to Fold, Unfold or Collapse1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Break; Crack
CUSTOMER REPORTED TWO OCCURRENCES WHERE THE SYRINGE TIP OF THE 60 ML LUER-LOCK SYRINGE FRACTURED WHILE UNSCREWING THE LUER-LOCK CONNECTION FROM THE EASYPUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518040 ↗MalfunctionJun 20, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
AS A REPLACEMENT FOR THE INITIAL PRODUCT WHICH IS OUT OF STOCK, WE ARE RECEIVING THE COMPANY SOL-MILLENIUM MEDICAL. THE PISTON OF THESE SYRINGES <SLIDE> AND IT IS VERY DIFFICULT TO ADJUST A VOLUME. THE PISTON MOVES AS SOON AS WE NO LONGER HOLD IT IN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295927 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: FOR YOU INFORMATION AND TO BE DOCUMENTED, LAST BATCH THAT DELIVERED TO (B)(6) HOSPITAL THROUGH ARABIAN HEALTH CARE HAS QUALITY ISSUE ( 2 SYRINGES HAS A PLASTIC PARTICLE INSIDE THE SYRINGE PLUNGER) BLOW MORE DETAILS REGARDING THE ITEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035445 ↗
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
- 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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