Medline Industries, Inc. DYNJ60343CRecalls & reported problems
Medline Industries, Inc. · I.R. PACK · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327285043), received between Apr 2, 2024 and Sep 23, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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
- May 18, 2023Open, Classified
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2161-2023 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Failure to Cut1
- Material Integrity Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Product Quality Problem; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873442 ↗MalfunctionApr 9, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE HANDLES ON THE SYRINGE DO NOT STAY ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19072047 ↗MalfunctionApr 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY "THE HANDLES ON THE SYRINGE DO NOT STAY ON".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19022616 ↗
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- Halyard SAMM066-15_0017Avid Medical, Inc. · Cardiac catheterization kit3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.