Excelsior E0103-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10363807103013), received between Jun 12, 2024 and Jun 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K130975); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.

   Z-2199-2025 · Root cause: Process control · 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.

• MalfunctionJun 12, 2024Material Integrity Problem; Material Integrity Problem

  SYRINGE CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 19523970 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130975. One submission often covers many models, so check the product and lot details in each record.

• Z-2116-2025 · Jun 3, 2025 · Open, Classified
  SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000