SOL-M 60ml Luer Lock Syringe w/o Needle (bulk ,sterile) P180060BSRecalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810018095239), received between May 16, 2025 and May 16, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination” (4 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.
Reports received per month
Most reported problems
Device problems
- Contamination4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED THAT SOMETHING RED WAS FOUND INSIDE THE (SECOND) 60ML SYRINGE. THE SYRINGES WERE CLEAN, AND ANESTHETIC HAD BEEN DRAWN. THE RED SUBSTANCE WAS NOTICED IN THE OPERATING ROOM BEFORE DRAWING THE ANESTHETIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035736 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: I WOULD LIKE TO INFORM YOU THAT DURING OUR PROCESS WE HAVE FOUND HAIR INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035665 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: WE HAVE A PRODUCT COMPLAINT THAT I WOULD LIKE TO REPORT IN REGARD TO YOUR 60 ML SYRINGE LUERLOCK. THIS MORNING WHILE OUR TECHNICIAN WAS USING THE 60 ML SYRINGE TO COMPOUND A MEDICATION A PIECE OF HAIR WAS FOUND LODGED INSIDE THE BARREL. NEEDLESS TO SAY, THIS WAS A BRAND NEW IN THE PACKAGE SYRINGE THAT WAS NEVER USED BEFORE. THIS RAISES CONCERN OVER QUALITY CONTROL AND WHETHER WE MAY TRUST SUCH PRODUCTS TO BE USED AT OUR FACILITIES. PLEASE ADVISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035627 ↗MalfunctionMay 16, 2025Contamination; Contamination
"CUSTOMER REPORTED: I WOULD LIKE TO INFORM YOU THAT DURING OUR PROCESS WE HAVE FOUND HAIR INSIDE THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035405 ↗
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
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- 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
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- 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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