Medline SPT-2201CSRecalls & reported problems
Medline Industries, Inc. · GOWN,POLY REINFORCED,LG · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40884389029702), received between Feb 23, 2023 and Feb 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Chemical Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
CHEMICAL BURN REQUIRING PRESCIPTION TREATMENT.
Patient problems: Chemical Exposure
MAUDE report 16432771 ↗
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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