NAMIC 60022026Recalls & reported problems
Medline Industries, Inc. · MTS LHK BHS BAPTIST LOUISVILLE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489087253), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 25, 2026Open, Classified
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1836-2026 · Root cause: No Marketing Application · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loose or Intermittent Connection
It was reported that the syringe would over rotate on the manifold and would not lock. This allows the syringe to back off and become loose to allow air into the lines.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931847 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.