Medline Industries, Inc. DYNJ89754Recalls & reported problems
Medline Industries, Inc. · OH CORONARY FEMORAL PACK · Class 2
Data updated Oct 18, 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 10198459289798), received between Nov 24, 2025 and Sep 14, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Contamination1
- Crack1
- Insufficient Device Problem Information1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765008 ↗MalfunctionAug 11, 2026Contamination; Insufficient Device Problem Information
It was reported that "linting OR towels and gauze in both packs."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208891 ↗MalfunctionNov 26, 2025Crack; Sharp Edges; Crack; Sharp Edges
A SYRINGE WAS FOUND WITH ONE WING CRACKED AND HAD SHARP EDGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660710 ↗MalfunctionNov 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SYRINGES "AREN'T DRAWING UP PROPERLY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23640465 ↗
Other Cardiovascular procedure kit devices
- Medline Industries, Inc. CDS840396YMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS983513FMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. DYNJ51038RMedline Industries, Inc. · Cardiovascular procedure kit4 recalls2 reports
- NAMIC 60033123Medline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ905079FMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- 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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