CARDINAL HEALTH SOP40KARIDRecalls & reported problems
Cardinal Health 200, LLC · STERILE KNEE ARTHROSCOPY PACK · Class 1
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 10887488826073), received between May 11, 2018 and May 11, 2018 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN REPORTED HE HAD DEVELOPED AN ALLERGIC REACTION/RASH TO THE BILATERAL DORSUM OF THE HANDS FROM SOMETHING IN THE KNEE ARTHROSCOPY PACK/ SOP40KARID BELIEVED TO BE CAUSED BY THE SPECIALTY SMART GOWN (B)(4). ORAL AND TOPICAL STEROIDS WERE PRESCRIBED WITH GOOD RESULTS.
Patient problems: Reaction
MAUDE report 7506454 ↗
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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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