DeRoyal 89-7647Recalls & reported problems
Deroyal Industries, Inc. · SINGLE BASIN PACK · Class 2
Data updated Oct 13, 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 00749756750288), received between Nov 13, 2018 and Nov 13, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2018Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem
A CONVENIENCE KIT CONTAINED GAUZE WITH STRANDS COMING OFF OF IT. THE STRANDS ARE AN ISSUE IN THE SURGICAL FIELD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8063716 ↗
Other General surgery tray devices
- Halyard MSBM036-03_0012Avid Medical, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ58534Medline Industries, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ82007AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Halyard KRIV26-02_0003Avid Medical, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ63410Medline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ908124AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. CDS983467JMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 recalls0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page