HalyardRecalls & reported problems across all models

We found 9 models of Halyard by Owens & Minor Distribution, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2025 and Jan 16, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Explosion” (2 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Halyard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 6, 2023Class IOpen, 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 · names 5 of these models · Recall details · FDA record ↗

2. Nov 6, 2023Class IOpen, 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 · names 3 of these models · Recall details · FDA record ↗

Most reported Halyard problems

Halyard models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Halyard SS010

  Saline, vascular access flush
  1 recall2 reports
• Halyard SS005

  Saline, vascular access flush
  1 recall0 reports
• Halyard SS003

  Saline, vascular access flush
  1 recall0 reports
• Halyard 49148

  Dressing, wound, drug
  1 recall0 reports
• Halyard 49151

  Dressing, wound, drug
  1 recall0 reports
• Halyard 49153

  Dressing, wound, drug
  1 recall0 reports
• Halyard 49154

  Dressing, wound, drug
  1 recall0 reports
• Halyard 49155

  Dressing, wound, drug
  1 recall0 reports
• Halyard 51775

  PACK, HOT OR COLD, DISPOSABLE
  2 reports

Recent Halyard adverse event reports

The 4 most recent reports across all models, 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 ↗
• InjuryJun 3, 2025Explosion; Explosion

  THE NURSE REPORTED HEAT PACK EXPLODED OVER MOM AND BABY. SHE STATED THAT SHE WENT INTO THE ROOM AND IMMEDIATELY GRABBED THE BABY TO WASH HIM OFF BECAUSE HE WAS COVERED IN THE CONTENTS FROM THE HEAT PACK. THE PATIENT STATED SHE FELT LIKE HER FACE WAS BURNING AS THE CONTENTS GOT INTO HER LEFT EYE. THE NURSE IMMEDIATELY WASHED OUT THE MOM'S EYES. THE NURSE STATED SHE WANTED TO GET THE BABY CLEANED UP QUICKLY AND GET MOM ASSESSED BY HER OB DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136584 ↗
• InjuryJun 3, 2025Explosion; Explosion

  THE NURSE REPORTED HEAT PACK EXPLODED ALL OVER MOM AND BABY. SHE STATED THAT SHE WENT INTO THE ROOM AND IMMEDIATELY GRABBED THE BABY TO WASH HIM OFF BECAUSE HE WAS COVERED IN THE CONTENTS FROM THE HEAT PACK. THE PATIENT STATED SHE FELT LIKE HER FACE WAS BURNING AS THE CONTENTS GOT INTO HER LEFT EYE. THE NURSE IMMEDIATELY WASHED OUT THE MOM'S EYES. THE NURSE STATED SHE WANTED TO GET THE BABY CLEANED UP QUICKLY AND HAVE MOM ASSESSED BY HER OB DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Eye Burn

  MAUDE report 22136583 ↗

Other Owens & Minor Distribution, Inc. products

• MediChoice6 models · 6 reports · 1 recall