Halyard SS010Recalls & reported problems
Owens & Minor Distribution, Inc. · Prefilled Syringe Saline Flush Intravenous 10ML PP Clear Not Made with Natural Rubber Latex Halyard · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885632389757), received between Jun 24, 2025 and Jan 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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 (K150143); 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.
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-0511-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Defective Device1
- Filling Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026
FLUSH CAP FOUND TO BE MELTED/DEFORMED AFTER OPENING PACKAGING. CLEAR TIP OF FLUSH ALSO DEFORMED. THIS IS NOT THE FIRST ONE FOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092930 ↗MalfunctionJun 24, 2025Filling Problem; Defective Device
PRE-FILLED SYRINGE WAS NOTED TO BE FILLED WITH AIR INSTEAD OF SALINE.
Patient problems: Insufficient Information
MAUDE report 22318020 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150143. One submission often covers many models, so check the product and lot details in each record.
- Z-0926-2017 · Oct 4, 2016 · TerminatedNormal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
Other Saline, vascular access flush devices
- BD PosiFlush 306553Becton, Dickinson And Company · Saline, vascular access flush89 reports
- Excelsior 10011Medline Industries, Inc. · Saline, vascular access flush1 recall6 reports
- ARROW IPN927748Teleflex Incorporated · Saline, vascular access flush1 recall4 reports
- Normal Saline IV Flush Syringe 10mL in 12mL syringeMedefil, Inc. · Saline, Vascular Access Flush1 recall1 report
- Excelsior E0103-01Medline Industries, Inc. · Saline, vascular access flush1 recall1 report
- McKesson 191-MIS-1130Mckesson Medical-Surgical Inc. · Saline, Vascular Access Flush1 recall0 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
- Halyard SS003Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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