Medline Industries, Inc. DYNJ56386DRecalls & reported problems
Medline Industries, Inc. · NON-VASCULAR PACK · Class 2
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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10198459123382), received between Jan 29, 2026 and Mar 4, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. 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
- Feb 27, 2026Class IIOpen, Classified
Unapproved design changes to the products outside of the 510(k) clearance.
Z-1890-2026 · Root cause: Component change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
Patient problems
- Insufficient Information1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2026 THE SURGEON "GOT A SIGNIFICANT CUT IN HIS PALM HAND WHILE PERFORMING A CEREBRAL ANGIO" WHEN A "GREEN SYRINGE 10CC FROM THE IR NON VASCULAR PACK" BROKE DURING USE.
Patient problems: Laceration(s)
MAUDE report 24505894 ↗MalfunctionJan 29, 2026Material Integrity Problem
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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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