Medline LLADRecalls & reported problems
Medline Industries, Inc. · LUER LOCK ACCESS DEVICE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 112
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10193489103212), received between Jun 28, 2024 and Sep 30, 2026 — classified as 2 injuries, 110 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (80 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
- Fluid/Blood Leak80
- Retraction Problem19
- Detachment of Device or Device Component9
- Physical Resistance/Sticking9
- Break7
- Insufficient Device Problem Information6
- Material Integrity Problem4
- Failure to Disconnect3
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- Hemorrhage/Blood Loss/Bleeding20
- Exposure to Body Fluids9
- Needle Stick/Puncture7
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Emotional Changes1
- Stroke/CVA1
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: Needle Stick/Puncture
MAUDE report 50955114 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950907 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Infusion or Flow Problem
It was reported that "Intermittent issues with the vacutainers being problematic and the staff needing to really push down the tube to get blood to transfer. A nurse sent these images attached and explained that the vacutainer was challenging to remove the blood tube and when they did, blood was spurting from the needle in the vacutainer."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947816 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that ¿Lot# 89724040002 is leaking from the Blue Neck leading to the Needle.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946240 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that ¿The rubber stopper inside the device is not coming down to cover the needle when the tube is removed. Thus, causing blood to leak from the Device.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945741 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936485 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50936389 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935000 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "The plastic part covering the needle in the tube is sometimes leadking blood."
Patient problems: Needle Stick/Puncture
MAUDE report 50932828 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "The plastic part covering the needle in the tube is sometimes leadking blood."
Patient problems: Needle Stick/Puncture
MAUDE report 50932803 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50932794 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "The plastic part covering the needle in the tube is sometimes leaking blood".
Patient problems: Needle Stick/Puncture
MAUDE report 50931838 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50931829 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926255 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923024 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Infusion or Flow Problem; Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920556 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918742 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Physical Resistance/Sticking
It was reported that "Staff have been reporting the vacutainers are ¿leaking blood¿. The plastic stopper is getting stuck and blood leaks all over."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916934 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Physical Resistance/Sticking
It was reported that "Staff have been reporting the vacutainers are ¿leaking blood¿. The plastic stopper is getting stuck and blood leaks all over."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916926 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916922 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "Blood leaking out of LLAD" and "the issue is occurring with the vacutainer/transfer device when it is hooked up to an IV for blood draw." "The two instances shared with me were that the blood is spilling outside of the tube/transfer device but also still filling the tube. One occurrence resulted in blood forcefully coming out of the transfer device and onto the wall of a patient¿s room."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916256 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "Westchester emergency department experienced hub breakage, and clinical stated they continue to experience issues with the needle sheath and blood leakage" and "I've received the same complaints from various departments regarding the hub breaking."
Patient problems: Stroke/CVA
MAUDE report 50915683 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "Sheath is not retracting back over the needle after the blood collection tube is removed causing blood to free flow onto the floor, nurse, patient."
Patient problems: Exposure to Body Fluids
MAUDE report 50915681 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "The grey rubber needle cover is not moving back over the needle once they draw blood and this causes blood to free flow."
Patient problems: Exposure to Body Fluids
MAUDE report 50915040 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Retraction Problem
It was reported that "The grey rubber needle cover is not moving back over the needle once they draw blood and this causes blood to free flow."
Patient problems: Exposure to Body Fluids
MAUDE report 50914969 ↗
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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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