Medline PCS1550Recalls & reported problems
Medline Industries, Inc. · SOLUTION,WATER,IRRIGATION,250ML,STRL · Class U
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196427055), received between Aug 17, 2026 and Sep 22, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 6, 2023Open, Classified
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Z-0513-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Contamination1
- Difficult to Open or Remove Packaging Material1
- Tear, Rip or Hole in Device Packaging1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Contamination
It was reported that "After looking at the product it has been discovered that it is not mold, it is a string (foreign object)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854774 ↗MalfunctionSep 21, 2026Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840650 ↗MalfunctionAug 17, 2026Unsealed Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50276444 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.