SOL-M Luer Lock Syringe with Exchangeable NeedleRecalls & reported problems across all models
Sol-Millennium Medical, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SOL-M Luer Lock Syringe with Exchangeable Needle model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 22 models of SOL-M Luer Lock Syringe with Exchangeable Needle by Sol-Millennium Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2019 and Mar 4, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Decoupling” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
SOL-M Luer Lock Syringe with Exchangeable Needle recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 9, 2024Open, 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 · names 22 of these models · Recall details · FDA record ↗
Most reported SOL-M Luer Lock Syringe with Exchangeable Needle problems
Device problems
- Decoupling3
- Crack2
- Break1
- Defective Component1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Chemical Exposure1
- Radiation Exposure, Unintended1
SOL-M Luer Lock Syringe with Exchangeable Needle models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832110TSyringe, piston1 recall2 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852110TSyringe, piston1 recall2 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832310Syringe, piston1 recall1 report
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1812110Syringe, piston1 recall1 report
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832558Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832210Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832515Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832510Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832215Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832110Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832115Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852215Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852115Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852010Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1812210Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1812115Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1812010Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1812015Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1832010Syringe, piston1 recall0 reports
- SOL-M™ Luer Lock Syringe with Exchangeable Needle 1852010TSyringe, piston1 recall0 reports
- 1 recall0 reports
- 1 recall0 reports
Recent SOL-M Luer Lock Syringe with Exchangeable Needle adverse event reports
The 6 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break; Crack
CUSTOMER REPORTED THAT THE SOL-MILLENNIUM SYRINGE "SPLIT" DURING THE INJECTION OF PRODUCT FROM THE SYRINGE INTO AN IV BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505400 ↗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 ↗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 22, 2025Defective Component; Defective Component
CUSTOMER REPORTED - SLIPPERY BARREL ISSUE: USERS ARE FINDING THE SYRINGE BARREL TO BE EXCESSIVELY SLIPPERY, MAKING IT DIFFICULT TO MAINTAIN A FIRM GRIP AND CONTROL THE INJECTION. HARD-TO-PULL PLUNGER ISSUE: USERS ARE REPORTING THAT THE PLUNGER REQUIRES EXCESSIVE FORCE TO PULL, LEADING TO DIFFICULTIES IN ACCURATELY DRAWING UP MEDICATION, BLOOD EXTRACTION, AND CAUSING DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22073547 ↗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 ↗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 Sol-Millennium Medical, Inc. products
- SOL-M Syringe5 models · 15 reports · 1 recall
- SOL-CARE Syringe with Safety Needle8 models · 7 reports · 1 recall
- SOL-M Luer Lock Syringe w/Exch Needle2 models · 0 reports · 1 recall
- SOL-M Luer Lock Syringe w/Exch Needle Tray2 models · 0 reports · 1 recall
- SOL-M Luer Lock Syringe with Blunt Fill Needle3 models · 0 reports · 1 recall
- SOL-CARE Safety Needle11 models · 48 reports
- SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle6 models · 43 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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