Halyard 42216Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30680651422164), received between Jul 15, 2019 and Jul 26, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3005997949-2019-00013 FOR THE FIRST PATIENT. IT WAS REPORTED THAT THE "BACK TABLE COVERS HAVE LINT ON THEM AND THEY ARE BEING USED IN CATARACT CASES." ADDITIONAL INFORMATION WAS RECEIVED ON 3-JUL-2019 THAT STATES TWO PATIENTS HAD LINT IN THE SURGICAL SITE AND EYES AND A FOLLOW UP PROCEDURE FOR IRRIGATION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8833082 ↗
• 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 TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3005997949-2019-00014 FOR THE SECOND PATIENT. IT WAS REPORTED THAT THE "BACK TABLE COVERS HAVE LINT ON THEM AND THEY ARE BEING USED IN CATARACT CASES." ADDITIONAL INFORMATION WAS RECEIVED ON 3-JUL-2019 THAT STATES TWO PATIENTS HAD LINT IN THE SURGICAL SITE AND EYES AND A FOLLOW UP PROCEDURE FOR IRRIGATION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8832980 ↗
• MalfunctionJul 15, 2019Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available; Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON 15JUL2019. O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00002 FOR THE SECOND PATIENT-AVID MDR NUMBER 1047429-2019-00009. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00004 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. THE CUSTOMER REPORTED THE BACK-TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8789017 ↗
• MalfunctionJul 15, 2019Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available; Failure to Obtain Sample; Appropriate Device Problem Term/Code Not Available

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON (B)(6) 2019. O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00002 FOR THE SECOND PATIENT-AVID MDR NUMBER 1047429-2019-00009. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00005 FOR THE FIFTH PATIENT AVID MDR NUMBER 1047429-2019-00012. THE CUSTOMER REPORTED THE BACK-TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8788959 ↗
• MalfunctionJul 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00002 FOR THE SECOND PATIENT-AVID MDR NUMBER 1047429-2019-00009. REFER TO 3005997949-2019-00004 FOR THE FOURTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. REFER TO 3005997949-2019-00005 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00012. THE CUSTOMER REPORTED THE BACK-TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8788908 ↗
• MalfunctionJul 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON 15JUL2019. O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3005997949-2019-00001 FOR THE FIRST PATIENT-AVID MDR NUMBER 1047429-2019-00008. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00004 FOR THE FOURTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. REFER TO 3005997949-2019-00005 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00012. THE CUSTOMER REPORTED THE BACK-TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8788575 ↗
• MalfunctionJul 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON 15JUL2019. O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 3005997949-2019-00002 FOR THE SECOND PATIENT-AVID MDR NUMBER 1047429-2019-00009. REFER TO 3005997949-2019-00003 FOR THE THIRD PATIENT-AVID MDR NUMBER 1047429-2019-00010. REFER TO 3005997949-2019-00004 FOR THE FOURTH PATIENT-AVID MDR NUMBER 1047429-2019-00011. REFER TO 3005997949-2019-00005 FOR THE FIFTH PATIENT-AVID MDR NUMBER 1047429-2019-00012. THE CUSTOMER REPORTED THE BACK TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND IN THE PATIENT'S EYES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8788536 ↗