Medline Industries, Inc. DYNJP2402Recalls & reported problems
Medline Industries, Inc. · GOWN SIRUS NONREIN XL W/TWL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196744718), received between Nov 20, 2025 and Sep 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Jan 7, 2026Class IIOpen, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2129-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jan 7, 2026Class IIOpen, Classified
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-1424-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Biocompatibility1
- Material Frayed1
Patient problems
- Itching Sensation1
- No Clinical Signs, Symptoms or Conditions1
- Rash1
- Skin Burning Sensation1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948698 ↗InjuryNov 20, 2025Biocompatibility; Biocompatibility
ACCORDING TO THE FACILITY, GOWN CAUSED SKIN REACTION. PER THE FACILITY, "GOWN WAS ON FOR AN HOUR. ITCHING AND BURNING NOTED AFTER 30 MINUTES. RED RAISED RASH AROUND WHERE GOWN CUFFS WERE IN CONTACT WITH SKIN." THE FACILITY REPORTED THE SKIN IRRITATION RESOLVED WITH "WASHING OF THE SKIN AND ADMINISTRATION OF DEXAMETHASONE." THE INDIVIDUAL IS DOING "FINE."
Patient problems: Itching Sensation; Rash; Skin Burning Sensation; Swelling/ Edema
MAUDE report 23606042 ↗
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. DYNJP2401Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2702Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- MEDLINE DYNJP2368PMedline 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 · each recall links to the FDA recall notice
- 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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