DeRoyal 89-10578Recalls & reported problems
Deroyal Industries, Inc. · CMC VASCULAR ACCESS PACK · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00749756363495), received between Jun 27, 2022 and Aug 9, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem5
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
HAIR FOUND IN SPECIMEN CUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950919 ↗MalfunctionFeb 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
FOUND LARGE HAIR CLUMP IN PACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659858 ↗MalfunctionNov 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
HAIR ON BACK TABLE COVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18119518 ↗MalfunctionJul 25, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
UNIDENTIFIED MATERIAL NOTICED ON RAYTECS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17390795 ↗MalfunctionApr 18, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
HAIR FOUND IN BASIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16761036 ↗MalfunctionJun 27, 2022Material Puncture/Hole; Material Puncture/Hole
HOLE IN OUTER BLUE DRAPE, DID NOT PENETRATE PLASTIC BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14832096 ↗
Other General surgery tray devices
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- 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.
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