SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle 140065IMRecalls & reported problems
Sol-Millennium Medical, Inc. · Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries. 5ml LL Safety Syringe with 23g x 1 1/4" exchangeable needle · Class 2
All models of SOL-CARE Luer Lock Safety Syringe with Exchangeable Needle (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00818392011296), received between May 16, 2025 and Dec 2, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Decoupling2
- Component Missing1
- Contamination1
- Difficult to Fold, Unfold or Collapse1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Break; Leak/Splash; Break; Leak/Splash
CUSTOMER REPORTED THE SYRINGE RUPTURED. DURING BLOOD COLLECTION WITH AN EMPTY SYRINGE, BLOOD SPLATTERED. UPON INSPECTION, A CRACK WAS FOUND ON THE SYRINGE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692123 ↗MalfunctionAug 20, 2025Contamination; Contamination
CUSTOMER REPORTED THAT FOREIGN OBJECT INSIDE THE SYRINGE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22847519 ↗MalfunctionJun 20, 2025Break; Break
CUSTOMER REPORTED THAT THE NEEDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295037 ↗MalfunctionJun 20, 2025Decoupling; Decoupling
SOL-043 - CUSTOMER REPORTED THE NEEDLE SUDDENLY DETACHED, MAKING IT IMPOSSIBLE TO ADMINISTER THE MEDICATION. SOL-088 - CUSTOMER REPORTED THAT THE NEEDLE FELL OFF. SOL-101, SOL-102, SOL-103 - CUSTOMER REPORTED THAT THE NEEDLE DETACHED. SOL-111 - CUSTOMER REPORTED THAT THE NEEDLE HUB IS LOOSE. SOL-124 - CUSTOMER REPORTED THAT THE NEEDLE HUB IS LOOSE AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22295036 ↗MalfunctionJun 18, 2025Component Missing; Component Missing
CUSTOMER REPORTED THAT THE BACK OF THE SYRINGE IS MISSING A COMPONENT, RENDERING IT UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282342 ↗MalfunctionJun 18, 2025Break; Break
CUSTOMER REPORTED THAT THE CONNECTION BETWEEN THE SYRINGE AND THE NEEDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22282286 ↗MalfunctionJun 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO PUSH THE PLUNGER ALL THE WAY DOWN DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182336 ↗MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT THE AFTER DRAWING THE MEDICATION WITH A 5ML SAFETY INJECTION NEEDLE, THE NEEDLE HUB BECAME DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035633 ↗
Other SYRINGE, ANTISTICK devices
- BD Integra 305270Becton, Dickinson And Company · SYRINGE, ANTISTICK261 reports
- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS101235FMedline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page