Medline Industries, Inc. DYNJ45701BRecalls & reported problems
Medline Industries, Inc. · EXTREMITY PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489856279), received between Sep 3, 2025 and Sep 4, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Aug 8, 2025Class IOpen, Classified
Convenience kits labeled as sterile have not gone through the sterilization process.
Z-2593-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE FACILITY A NON-STERILE KIT WAS USED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974589 ↗InjurySep 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE FACILITY A NON-STERILE KIT WAS USED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22974503 ↗InjurySep 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE FACILITY A NON-STERILE KIT WAS USED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959794 ↗InjurySep 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE FACILITY A NON-STERILE KIT WAS USED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958759 ↗InjurySep 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
ACCORDING TO THE FACILITY A NON-STERILE KIT WAS USED DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22957427 ↗
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- Medline Industries, Inc. DYNJ909505AMedline Industries, Inc. · Orthopedic tray4 recalls1 report
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 · each recall links to the FDA recall notice
- 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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