Medline Industries, Inc. DYNJ58652CRecalls & reported problems
Medline Industries, Inc. · XI ROBOT PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489884067), received between May 14, 2026 and Jun 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Slipped1
- Extra Components1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2026Extra Components
IT WAS REPORTED THAT THERE WERE 6 BABY LAPS INSTEAD OF 5.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570003 ↗MalfunctionMay 14, 2026Device Slipped; Detachment of Device or Device Component
IT WAS REPORTED ON 04/14 THAT THE VELCRO DETACHED FROM THE DRAPE. AN APPROVED ALTERNATIVE DRAPE CLAMP WAS THEN APPLIED; HOWEVER, THE DRAPE SLIPPED THROUGH THE CLAMP. UPON ATTEMPTING TO RE-SECURE THE DRAPE, THE MATERIAL TORE AND THE DRAPE BROKE APART, RESULTING IN LOSS OF SECUREMENT OF THE SUCTION TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179104 ↗
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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
- 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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