Regard A3ISRGSTXL-REGRecalls & reported problems
Resource Optimization & Innovation, L.L.C. · AAMI Level 3 Surgical Gown, Reinforced SMS, Sterile X Large · Class 2
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 00326053117756), received between Sep 25, 2024 and Sep 25, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Exposure to Body Fluids1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
GOWN WAS DONNED BY SCRUB TECH DURING SURGICAL CASE. THE INDIVIDUAL NOTICED THAT HER SCRUBS FELT DAMP AGAINST HER SKIN WHERE THE OUTSIDE OF THE GOWN HAD BLOOD CASTOFF FROM PROCEDURE. UPON REMOVAL OF THE GOWN, SCRUB TECH DISCOVERED THAT HER SCRUBS HAD BLOOD SOAKED ONTO THEM FROM THE OUTSIDE OF THE GOWN.
Patient problems: Exposure to Body Fluids
MAUDE report 20304803 ↗
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 DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline Industries, Inc. DYNJP2401Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2702Medline 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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