Halyard 95828Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651958287), received between Nov 19, 2018 and Nov 19, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

14 other recalls cover devices cleared under the same FDA submission (K924065); 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2018-00040 FOR THE FIRST PATIENT. IT WAS REPORTED THAT A PEDIATRIC SURGEON STATED THE DIMENSIONS OF THE INTERNAL RETENTION WERE NOT CORRECT. IT WAS NOTED THAT IT CAUSED PARTIAL DISLOCATION AND GENERATED PERITONITIS.

  Patient problems: Peritonitis

  MAUDE report 8086658 ↗
• InjuryNov 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2018-00040 FOR THE SECOND PATIENT. IT WAS REPORTED THAT A PEDIATRIC SURGEON STATED THE DIMENSIONS OF THE INTERNAL RETENTION WERE NOT CORRECT. IT WAS NOTED THAT IT CAUSED PARTIAL DISLOCATION AND GENERATED PERITONITIS. IT WAS STATED THAT THIS WAS THE SECOND INCIDENT IN THE LAST MONTH.

  Patient problems: Peritonitis

  MAUDE report 8086649 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924065. One submission often covers many models, so check the product and lot details in each record.

• Z-2346-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
• Z-2342-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
• Z-2341-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
• Z-2352-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
• Z-2345-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
• Z-2347-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Comp
• Z-2343-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
• Z-2351-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
• Z-2350-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
• Z-2349-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
• Z-2348-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Z-2344-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL