SOL-M 10ml Luer Lock Syringe w/o Needle (bulk ,sterile) P180010BSRecalls & reported problems
Sol-Millennium Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810018095161), received between May 16, 2025 and Apr 24, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Break
CUSTOMER REPORTED THAT THE 10 ML SYRINGE FROM THE NASAL PACK CRACKED WHEN THE SURGEON WENT TO USE IT (MINIMAL PRESSURE APPLIED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24980013 ↗MalfunctionMar 23, 2026Break
CUSTOMER REPORTED DURING THE PROCEDURE, TWO SYRINGES CRACKED WHILE THE DOCTOR WAS INJECTING SALINE DURING THERMODILUTION MEASUREMENTS. UNFORTUNATELY, I AM WRITING TO CONFIRM THERE ARE NO PHOTOS/ VIDEOS OR UNUSED SAMPLES AVAILABLE, AND CUSTOMER DID NOT KEEP DEFECT SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661670 ↗MalfunctionDec 30, 2025Break; Break
CUSTOMER REPORTED THAT THE 10 ML LUER LOCK SYRINGE IS BROKEN IN THE TRAY. THE BREAKAGE IS CLEARLY VISIBLE ON ONE SYRINGE, WHILE THE OTHER HAS A CRACK THAT ONLY BECOMES APPARENT WHEN DRAWING UP LIQUID. THERE WAS ALSO A SYRINGE WITH A BROKEN LUER LOCK CONNECTION. UNFORTUNATELY, I CAN CONFIRM THAT THE SAMPLE AND PHOTOS ARE NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23921183 ↗MalfunctionDec 17, 2025Break; Break
CUSTOMER REPORTED SYRINGE HAD A SLIT IN IT. THE ISSUE IDENTIFIED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827094 ↗MalfunctionOct 30, 2025Break; Break
CUSTOMER REPORTED SYRINGE IN PACK FOUND TO BE CRACKED UPON OPENING SPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423627 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: THE CUSTOMER REPORTS THAT ON (B)(6) 2024, IN THE PLASTIC SURGERY BLOCK, USING SYRINGES OF 10ML LUER, THE SYRINGE 10ML L/L 3 PARTS CONC. WAS FIND DEFECTED. INDEED, SOME GREASE IN THE PLUNGER OF THE SYRINGE WAS FOUND AND A BLACK RUBBER REMAINED IN THE BODY OF THE SYRINGE. OBSERVED FAT IN THE PISTON OF THE SYRINGE AS WELL AS THE PRESENCE OF RUBBER IN THE BODY OF ANOTHER SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035715 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: THE CUSTOMER REPORTS THAT ON (B)(6) 2024, IN THE PLASTIC SURGERY BLOCK, USING SYRINGES OF 10ML LUER, THE SYRINGE 10ML L/L 3PARTS CONC. WAS FIND DEFECTED. INDEED, SOME GREASE IN THE PLUNGER OF THE SYRINGE WAS FOUND AND A BLACK RUBBER WAS REMAINED IN THE BODY OF THE SYRINGE. OBSERVED FAT IN THE PISTON OF THE SYRINGE AS WELL AS THE PRESENCE OF RUBBER IN THE BODY OF ANOTHER SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035694 ↗
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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