SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852110TRecalls & 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 10818392013693), received between Dec 6, 2019 and Dec 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Decoupling1
- Fluid/Blood Leak1
Patient problems
- Chemical Exposure1
- No Clinical Signs, Symptoms or Conditions1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE 3CC AND 5CC ARE BOTH ARRIVING WITH BARELY ANY NEEDLES ATTACHED, AND THE ONES THAT ARE ATTACHED WILL GET STUCK IN THE VIAL AFTER DRAWING THE DOSE AND THE SYRINGE WILL BE IN HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23921449 ↗MalfunctionDec 6, 2019Crack; Fluid/Blood Leak
SUS VOLUNTARY EVENT REPORT NUMBER: MW5090432. A VOLUNTARY EVENT FORM WAS RECEIVED FROM THE FDA AT (B)(6) BY POSTAL SERVICE MAIL ON 11/7/2019. PER THE VOLUNTARY EVENT REPORT, CUSTOMER REPORTED TO THE FDA THAT A 5CC SYRINGE HAD A HAIRLINE CRACK ALONG THE BARREL CAUSING LEAKAGE AND CONTAMINATION OF THE RADIOPHARMACEUTICAL. THE INTEGRITY AND STERILITY OF THE PRODUCT WAS COMPROMISED PER THE CUSTOMER. ON 12/3/2019 ADDITIONAL INFORMATION WAS RECEIVED. THE (B)(6) PHARMACIST PROVIDED A PICTURE OF THE CRACKED SYRINGE. THE PHARMACIST STATED THAT TC-99M MACRO AGGREGATED ALBUMIN WAS THE DRUG THAT WAS FILLED IN THE SYRINGE. THE EXACT DRUG LEAKAGE AMOUNT WAS NOT KNOWN. THE END USER WAS (B)(6) HOSPITAL. PER THE PHARMACIST, HOSPITAL PERSONNEL WAS CONTAMINATED WITH RADIOACTIVE MATERIAL, BUT THERE DOES NOT APPEAR TO HAVE BEEN A REPORTED INJURY. (B)(6) PHARMACIST PROVIDED THE CUSTOMER (END USER) INVESTIGATIVE REPORT. SUMMARY OF (B)(6) HOSPITAL INVESTIGATIVE REPORT: DURING A PROCEDURE ON (B)(6) 2019, THE DOCTOR GAVE THE SYRINGE A STRONGER PUSH AND THE FORCE OF THE INJECTION LEAKED THROUGH THE SYRINGE AT A CRACK DEFECT AND DOSE WAS INADVERTENTLY SPRAYED ONTO DOCTOR. THE PROCEDURE WAS ABORTED AFTER PATIE
Patient problems: Chemical Exposure; Radiation Exposure, Unintended
MAUDE report 9432985 ↗
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.
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