Halyard 48139Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20680651481393), received between Jun 6, 2023 and Aug 20, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Flaked

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351744 ↗
• MalfunctionNov 6, 2025Product Quality Problem; Product Quality Problem

  THE SURGERY DEPARTMENT AT COMMUNITY HOSPITAL REPORTED AN ISSUE INVOLVING HALYARD ABSORBENT TRAY LINERS LEAVING DEBRIS INSIDE INSTRUMENT KITS AFTER PROCESSING THROUGH THE STERILE PROCESSING DEPARTMENT (SPD). THE DEBRIS WAS DISCOVERED AT THE START OF A SURGICAL CASE, RESULTING IN THE PROCEDURE¿S CANCELLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493268 ↗
• MalfunctionNov 5, 2025Product Quality Problem; Product Quality Problem

  THE STERILIZATION PROCESS APPEARS TO HAVE ACTIVATED ADHESIVE AND FIBER FRAGMENTS ORIGINATING FROM THE HALYARD ABSORBENT TRAY LINER. ADHESIVE AND FIBERS WERE FOUND ON SURGICAL INSTRUMENTS. NO INJURY WAS REPORTED. TWO PROCEDURES (CORONARY ARTERY BYPASS GRAFT AND SPINE) WERE CANCELED AS RESULT OF DISCOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480402 ↗
• MalfunctionJul 11, 2025Product Quality Problem; Product Quality Problem

  BROWN STAINS WERE FOUND ON TRAY LINER AND INSTRUMENT. IMPLANTS HAD BEEN PLACED ON THE LINER FOR PROCEDURE AT TIME OF DISCOVERY OF THE FOREIGN MATERIAL. PROCEDURE WAS INITIALLY DELAYED AN HOUR AND HALF AS A RESULT, THEN RESCHEDULED. THE BACK TABLE WAS CONSIDERED STERILITY COMPROMISED UPON DISCOVERY OF THE STAINS. IMPLANTS WERE SCRUBBED AND RESTERILIZED FOR THE NEXT CASE. PATIENT WAS UNDER ANESTHESIA AT THE TIME OF DISCOVERY, THERE WERE NO OTHER KNOWN PATIENT AFFECTS PER COMPLAINT REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478521 ↗
• InjuryMay 28, 2024Material Discolored; Material Discolored

  BROWN SPOTS WERE REPORTED ON THE TRAY LINERS POST CUSTOMER STERILIZATION OF SURGICAL TRAYS. THE SITE REPORTED THERE WAS A DELAY IN SURGERY (VARYING) AND SOME CASES HAD TO BE CANCELLED AS A RESULT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19405169 ↗
• MalfunctionMay 13, 2024Product Quality Problem; Product Quality Problem

  THE TRAY LINER EXHIBITS BROWN STAINS. THE CUSTOMER STATED THIS HAS RESULTED IN DELAYS UP TO (6) HOURS AND MULTIPLE CANCELLATIONS OF CASES. NO INSTRUMENTS FROM THE TRAYS WERE USED ON PATIENTS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 19297124 ↗
• MalfunctionMar 13, 2024Flaked; Flaked

  THE NURSING TEAM FILED A COMPLAINT REGARDING WHITE PARTICLES FROM THE TRAY LINER FALLING OFF INTO THE INSTRUMENTATION TRAY UPON OPENING. THE PARTICLES WERE REPORTED TO AFFECT THE SURGICAL FIELD STERILITY. ATTEMPTS WERE MADE TO GATHER MORE INFORMATION REGARDING INCIDENT IMPACT ON (B)(6) 2024. THE CUSTOMER HAS NOT RESPONDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18895638 ↗
• InjuryJun 15, 2023Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER NOTICED LIGHT BROWN STAINING ON THE HALYARD 48139 TRAY LINERS. THIS INCIDENT OCCURRED SEVERAL TIMES CONSISTENTLY FOR A FEW DAYS AT THE HOSPITAL AND CAUSED THEM TO STOP STERILIZING TRAYS FOR A PERIOD OF TIME. NO PATIENTS WERE INJURED; HOWEVER, SURGERY DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140411 ↗
• InjuryJun 6, 2023Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER NOTICED LIGHT BROWN STAINING ON THE HALYARD 48139 TRAY LINERS. THIS INCIDENT OCCURRED SEVERAL TIMES CONSISTENTLY FOR A FEW DAYS AT THE HOSPITAL AND CAUSED THEM TO STOP STERILIZING TRAYS FOR A PERIOD OF TIME. NO PATIENTS WERE INJURED; HOWEVER, SURGERY DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076256 ↗