MEDLINE INDUSTRIES, INC. DYNJT4722Recalls & reported problems
Medline Industries, Inc. · EP MAJOR PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10198459454820), received between Jan 7, 2026 and Sep 22, 2026 — classified as 3 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
- Crack1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break; Crack; Material Twisted/Bent
It was reported that "components are broken or mishaped within the packs, the packs show no signs of damage on the shelf or when being opened. Components with shown to have defects: BD 10 mL Syringe (found in 2 seperate packs) Pitcher (found 3 seperate packs) Basin."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854184 ↗MalfunctionJan 8, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, A SYRINGE BROKE. THERE WERE NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004117 ↗MalfunctionJan 7, 2026Break
IT WAS REPORTED THAT "COMPONENTS ARE BROKEN OR MISSHAPED WITHIN THE PACKS" INCLUDING "SYRINGE WAS BROKEN AND DAMAGED PITCHER."
Patient problems: Insufficient Information
MAUDE report 23989077 ↗
Other Cardiovascular procedure kit devices
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- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
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- Medline Industries, Inc. DYNJ0376608OMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 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.
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