Medline SPT-2208CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 40080196029755), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Nov 29, 2023Open, Classified

   Surgical gowns were manufactured with the wrong sleeve.

   Z-0711-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Nonstandard Device

  It was reported that "their technician who is cleaning scopes in the scope room has complained of getting wet through the gown"; "Specifically, it¿s the seam on the sleeves"; "She¿s getting wet on the sleeves"; "She is not getting wet on the trunk."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897371 ↗