MEDLINE OGBCS23GRecalls & reported problems
Medline Industries, Inc. · BLOOD COLLECTION SET, 23GX0.75 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10197344112081), received between Sep 15, 2026 and Sep 23, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that "the tubes/tube holders keep popping out when they are drawing blood. The tube holders are not screwing on strong enough it seems."
Patient problems: Needle Stick/Puncture
MAUDE report 50872367 ↗MalfunctionSep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50841032 ↗MalfunctionSep 16, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794873 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
It was reported that "When inserting the blood collection tube into the holder the needle will pop out of the holder".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772642 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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