DeRoyal 72-8000NSRecalls & reported problems
Deroyal Industries, Inc. · UmbiliCup™ · Class 2
Data updated Oct 16, 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 00749756331951), received between Oct 5, 2018 and Oct 5, 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROVIDER WAS PRICKED BY THE NEEDLE UNDER THE GRAY RUBBER.
Patient problems: No Patient Involvement
MAUDE report 7939127 ↗
Other CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS devices
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- IMUGARD 41950Terumo Bct, Inc. · Container, Empty, For Collection & Processing Of Blood & Blood Components21 reports
- CryoMACS® Freezing Bag 250 74401Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components20 reports
- CryoMACS® Freezing Bag 750 74403Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components14 reports
- CryoMACS® Freezing Bag 50 74400Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components6 reports
- CryoMACS® Freezing Bag 1000 74404Miltenyi Biotec B.V. & Co. KG · Container, Empty, For Collection & Processing Of Blood & Blood Components1 report
- Cryostore CS50SOrigen Biomedical, Inc. · Container, Empty, For Collection & Processing Of Blood & Blood Components1 report
- Transfer Pack 4R2014Fenwal, Inc. · Container, Empty, For Collection & Processing Of Blood & Blood Components1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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