McKesson 159-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479224183), received between Jan 27, 2023 and May 21, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT A PATIENT REQUIRED STITCHES TO THE BACK OF THE THROAT FOLLOWING THE USE OF AN LARYNGEAL MASK AIRWAY SIZE 5 FROM MCKESSON. THE CRNA NOTED THAT THE PLASTIC APPEARED TO BE HARDER COMPARED TO A PREVIOUSLY USED PRODUCT (TELEFLEX). THE PATIENT WAS ADVISED TO FOLLOW UP WITH THE SURGEON IF ANY ISSUES ARISE. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME WAS PROVIDED.

  Patient problems: Laceration(s)

  MAUDE report 25244654 ↗
• MalfunctionDec 18, 2025Collapse; Collapse

  SUNMED HOLDINGS LLC. 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 1314417-2025-00106 FOR THE FIRST REPORT. REFER TO 1314417-2025-00107 FOR THE SECOND REPORT. REFER TO 1314417-2025-00108 FOR THE THIRD REPORT. REFER TO 1314417-2025-00109 FOR THE FOURTH REPORT. IT WAS REPORTED, THE LARYNGEAL MASK AIRWAY (LMA) COLLAPSED DURING SURGERY. THERE WAS NO REPORT OF A DELAY IN THERAPY, HURT, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23846379 ↗
• MalfunctionJan 27, 2023Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  THE LMA WAS BEING REMOVED FROM THE AIRWAY AND THE LMA MASK PORTION THAT SEALS AGAINST THE AIRWAY IN THE PATIENT'S THROAT PARTIALLY SEPARATED FROM THE TUBE GETTING LODGED IN THE BACK OF THE PATIENT'S THROAT AND HAD TO BE EXTRACTED WITH A FORCEPS. THE ITEM WAS INSERTED INTO THE PATIENT'S AIRWAY AND REMAINED IN PLACE DURING THE SURGICAL PROCEDURE AS DESIGNED. ONCE PROCEDURE ENDED THE AND THE LMA WAS BEING REMOVED FROM THE AIRWAY THE LMA MASK PORTION THAT SEALS AGAINST THE AIRWAY IN THE PATIENT'S THROAT PARTIALLY SEPARATED FROM THE TUBE GETTING LODGED IN THE BACK OF THE PATIENT'S THROAT AND HAD TO BE EXTRACTED WITH A KELLY FORCEPS.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16258218 ↗