CONVERTORS 9515Recalls & reported problems
Cardinal Health 200, LLC · Non-reinforced Surgical Gown · Class 2
All models of CONVERTORS (38)
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 10885380153563), received between Jun 5, 2019 and Jun 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
- Product Quality 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.
MalfunctionJun 5, 2019Material Puncture/Hole; Product Quality Problem
THREE ISSUES WITH SURGICAL GOWNS:(1) SURGICAL GOWN WAS OPENED FOR SURGEON TO DON AND HE NOTICED A HOLE IN THE MID SECTION OF THE GOWN. (2) SURGICAL GOWN TIES ARE TORN (TORN FROM INSIDE AND THE INSIDE TIE BROKE OFF). (3) SURGICAL GOWN IS COMING APART NEAR THE WRIST (HAS A HOLE IN THE SEAM). TWO GOWNS ARE REF: (B)(4) AND LOT: 18LWQ004; ONE GOWN IS REF: (B)(4) AND LOT: 18KBJ029.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8669752 ↗
Other GOWN, SURGICAL devices
- Medline DYNJP2001SMedline Industries, Inc. · GOWN, SURGICAL2 recalls9 reports
- Medline DYNJP2202SMedline Industries, Inc. · GOWN, SURGICAL2 recalls5 reports
- MEDLINE DYNJP2002SMedline Industries, Inc. · GOWN, SURGICAL2 recalls4 reports
- Medline DYNJP2602Medline Industries, Inc. · GOWN, SURGICAL2 recalls3 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- MEDLINE DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline DYNJP2103Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2203Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 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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