Medline Industries, Inc. DYKE1568BRecalls & reported problems
Medline Industries, Inc. · PRIMARY KIT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489869125), received between Sep 22, 2026 and Sep 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Suction Problem” (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
- Suction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Suction Problem
It was reported that "Suction canister inside the pack is not maintaining suction when being used for procedure."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855912 ↗
Other General surgery tray devices
- Halyard MSBM036-03_0012Avid Medical, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ58534Medline Industries, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ82007AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page