Medline Industries, Inc. DYNJ23486Recalls & reported problems
Medline Industries, Inc. · ACDF/DISC PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196770052), received between Jul 1, 2024 and Jul 16, 2024 — classified as 2 injuries.
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
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2024 THE PATIENT EXPERIENCED A SKIN REACTION RELATED TO THE USE OF THE SUREPREP WIPE.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19750034 ↗InjuryJul 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 2024 THE PATIENT EXPERIENCED A SKIN REACTION RELATED TO THE USE OF THE SUREPREP WIPE.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19644708 ↗
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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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