Medline Industries, Inc. DYNJ87591Recalls & reported problems
Medline Industries, Inc. · TPLO PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10198459046513), received between Sep 12, 2025 and Aug 13, 2026 — classified as 2 injuries, 1 malfunction.
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
- Break1
- Crack1
- Material Frayed1
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233876 ↗InjurySep 19, 2025Material Integrity Problem; Material Integrity Problem
InjurySep 12, 2025Material Frayed; Material Frayed
ACCORDING TO THE CUSTOMER, FOR THE LAST "4-6 WEEKS" THE GAUZE IS "SHEDDING THREADS" INTO THE SURGICAL INCISIONS AND ON THE END TABLE WHILE "ABSORBING FLUID IN A SURGICAL INCISION".
Patient problems: Foreign Body In Patient
MAUDE report 23040322 ↗
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- Medline Industries, Inc. DYNJ42382BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ44866PMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNDL1350AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ69692Medline Industries, Inc. · General surgery tray4 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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