Halyard 42223Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 30680651422232), received between Jul 26, 2019 and Jul 26, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (5 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. PLEASE REFER TO (B)(4) FOR THE FIRST INCIDENT AND PATIENT. THIS IS THE FIFTH OF THE FIVE REMAINING REPORTS. REFER TO 3005997949-2019-00007 FOR THE FIRST PATIENT. REFER TO 3005997949-2019-00008 FOR THE SECOND PATIENT. REFER TO 3005997949-2019-00009 FOR THE THIRD PATIENT. REFER TO 3005997949-2019-00010 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT THERE WERE SIX INSTANCES WHERE THE BACK TABLE COVER IS LINTING AND LEAVING SPECS IN THE PATIENT'S EYES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834176 ↗
• MalfunctionJul 26, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. PLEASE REFER TO (B)(4) FOR THE FIRST INCIDENT AND PATIENT. THIS IS THE FOURTH OF THE FIVE REMAINING REPORTS. REFER TO 3005997949-2019-00007 FOR THE FIRST PATIENT. REFER TO 3005997949-2019-00008 FOR THE SECOND PATIENT. REFER TO 3005997949-2019-00009 FOR THE THIRD PATIENT. REFER TO 3005997949-2019-00011 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT THERE WERE SIX INSTANCES WHERE THE BACK TABLE COVER IS LINTING AND LEAVING SPECS IN THE PATIENT'S EYES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834174 ↗
• MalfunctionJul 26, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. PLEASE REFER TO (B)(4) FOR THE FIRST INCIDENT AND PATIENT. THIS IS THE THIRD OF THE FIVE REMAINING REPORTS. REFER TO 3005997949-2019-00007 FOR THE FIRST PATIENT. REFER TO 3005997949-2019-00008 FOR THE THIRD PATIENT. REFER TO 3005997949-2019-00010 FOR THE FOURTH PATIENT. REFER TO 3005997949-2019-00011 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT THERE WERE SIX INSTANCES WHERE THE BACK TABLE COVER IS LINTING AND LEAVING SPECS IN THE PATIENT'S EYES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834167 ↗
• MalfunctionJul 26, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. PLEASE REFER TO (B)(4) FOR THE FIRST INCIDENT AND PATIENT. THIS IS THE SECOND OF THE FIVE REMAINING REPORTS. REFER TO 3005997949-2019-00007 FOR THE FIRST PATIENT. REFER TO 3005997949-2019-00009 FOR THE THIRD PATIENT. REFER TO 3005997949-2019-00010 FOR THE FOURTH PATIENT. REFER TO 3005997949-2019-00011 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT THERE WERE SIX INSTANCES WHERE THE BACK TABLE COVER IS LINTING AND LEAVING SPECS IN THE PATIENT'S EYES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834148 ↗
• MalfunctionJul 26, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. PLEASE REFER TO (B)(4) FOR THE FIRST INCIDENT AND PATIENT. THIS IS THE FIRST OF THE FIVE REMAINING REPORTS. REFER TO 3005997949-2019-00008 FOR THE SECOND PATIENT. REFER TO 3005997949-2019-00009 FOR THE THIRD PATIENT. REFER TO 3005997949-2019-00010 FOR THE FOURTH PATIENT. REFER TO 3005997949-2019-00011 FOR THE FIFTH PATIENT. IT WAS REPORTED THAT THERE WERE SIX INSTANCES WHERE THE BACK TABLE COVER IS LINTING AND LEAVING SPECS IN THE PATIENT'S EYES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8834121 ↗