Medline Industries, Inc. DYNJMAST01Recalls & reported problems
Medline Industries, Inc. · MINI ACCESS 4 FR/SS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277538832), received between Nov 24, 2020 and Apr 21, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 reports).
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.
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2023Break; Break
ACCORDING TO THE CUSTOMER, "ITEM BROKE DURING PATIENT USE AND WAS STUCK INSIDE PATIENT.".
Patient problems: Foreign Body In Patient
MAUDE report 16787609 ↗InjuryNov 24, 2020Break
THE FACILITY REPORTED THAT THE DILATOR BROKE OFF IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10895113 ↗InjuryNov 24, 2020Break
THE FACILITY REPORTED THAT THE DILATOR BROKE OFF IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 10894897 ↗
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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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