Halyard 47117Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20680651471172), received between Jan 29, 2018 and Aug 1, 2023 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 8, 2024Open, Classified

   Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

   Z-0728-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Break; Break

  CUSTOMER CONTINUES TO HAVE ISSUES WITH MASK 47117. MASK RIPS EASILY, NOSE PIECE POPS OUTS DURING USE WITH COVID PATIENTS. SEVERAL STAFF MEMBERS NOTICED THE PRODUCT WAS FALLING APART, AND NOSE PIECE WOULD COME OUT EVEN BEFORE WEAR. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435631 ↗
• MalfunctionJun 30, 2023Break; Break

  LOOP FROM MASK TORE WHILE APPLYING FIRST TIME. THERE WERE 3 MASKS FROM THE BOX THAT THE SAME THING HAPPENED. 1 LOOP TORE OFF MASK ON FIRST APPLICATION. MASK WAS IN USE FOR COVID PANDEMIC PPE REQUIREMENT. THIS COMPLAINT WAS DISCOVERED DURING COMPLETION OF GLOBAL POST MARKET SURVEILLANCE REPORT MAUDE SEARCH PERFORMED ON JUNE 9TH, 2023. THE MAUDE REFERENCE NUMBER IS (B)(4). THE SITE WAS UNABLE TO LOCATE A DIRECT COMPLAINT RECEIVED FOR THIS ISSUE/INCIDENT FROM THE REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17241667 ↗
• MalfunctionJun 27, 2023Break; Break

  THE MASK ARE SO THIN THEY RIP VERY EASILY. THE STRINGS PULL AWAY FROM MASK AND THE MASKS ARE TEARING ALONG THE CHEEKS. WE GO THROUGH TWICE AS MANY OF THESE MASKS BECAUSE OF THE POOR QUALITY AND HAVING TO SWITCH THEM OUT OFTEN. I HAD A NURSE THAT HER NOSE CAME THROUGH ONE OF THE YELLOW MASKS BECAUSE SHE HAD BEEN IN AN ISOLATION ROOM AND HAD SOME SWEAT BUILD UP AND IT TORE RIGHT THROUGH THE MASK. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208627 ↗
• MalfunctionJun 12, 2023Break; Break

  "THE SIDES OF THE MASKS RIP OPEN, SOMETIMES WITH SPEECH ONLY. ITS ALMOST AS IF THE GLUE IN THE FOLDS HAS DRIED UP. THE STRAPS ALSO FREQUENTLY BREAK IN A CORNER CAUSING THE MASK TO FALL OPEN DURING PATIENT CARE WITH EXPOSURE IN THE COVID UNIT." THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME. PLEASE NOTE THAT IN THIS INCIDENT, THE REPORTER HAS INDICATED THAT NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108444 ↗
• InjuryOct 18, 2022Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED SHE EXHIBITED A REACTION ON HER FACE AND NECK AS A RESULT OF MASK USE. ON (B)(6) 2022, CUSTOMER REPORTED ITCHING/BURNING. CUSTOMER TREATED WITH ANTIHISTAMINE AND CORTISONE CREAM. ON 01SEP2022, CUSTOMER REPORTED ITCHING/BURNING SENSATION, INCREASED REDNESS, OOZING BEHIND EARS, PROGRESSION OF IRRITATION TO EYES, FOREHEAD, NECK AND CHEST AREAS. ON (B)(6) 2022, PHYSICIAN PRESCRIBED PREDNISONE SHOT AND ORAL PREDNISONE FOR CONTACT DERMATITIS AND RASH. THE FOLLOWING WEEK, SKIN REACTION PROGRESSED THROUGHOUT BODY WITH VARIOUS SPOTS, BLISTERS, AND PATCHES OCCURRING (ABDOMEN, ARMS, BACK, UPPER LEGS, BEHIND KNEES). ON (B)(6) 2022, THE CUSTOMER WAS PRESCRIBED MORE PREDNISONE. THE SKIN REACTIONS CONTINUED TO FLARE IN SOME SPOTS AND THIGH AREAS. ON (B)(6) 2022, PHYSICIAN PRESCRIBED ADDITIONAL PREDNISONE 60MG PER DAY AND REFERRED CUSTOMER TO ALLERGIST/IMMUNOLOGIST. ON (B)(6) 2022, ALLERGIST CONFIRM REACTION. NO FURTHER UPDATES FROM CUSTOMER ARE AVAILABLE THEREAFTER.

  Patient problems: Local Reaction

  MAUDE report 15624286 ↗
• InjuryJul 7, 2021Compatibility Problem; Compatibility Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUNE-2021 THAT STATES AN ALLERGIC REACTIONS OCCURRED ON THE YELLOW PROCEDURE MASK. THE CUSTOMER REPORTED THE FOLLOWING SYSTEMS: DIFFICULTY BREATHING, A HEADACHE, AND NAUSEA. THE MEDICATIONS PRESCRIBED TO THE CUSTOMER WAS A STEROID CREAM TO APPLIED TO THE FACE, RECEIVED A RESCUE INHALER, AND PRESCRIBED ZOFRAN. THE CUSTOMER IS AWAITING A REFERRAL TO SEE A DERMATOLOGIST.

  Patient problems: Local Reaction

  MAUDE report 12130772 ↗
• InjuryOct 22, 2020Component Incompatible; Component Incompatible

  IT WAS REPORTED THAT AN EMPLOYEE WORE A MASK FOR APPROXIMATELY FOUR HOURS AND HAD RESPIRATORY INFLAMMATION, SWELLING OF THE TONGUE AND WAS SENT TO THE EMERGENCY ROOM FOR TREATMENT.

  Patient problems: Reaction; Respiratory Distress

  MAUDE report 10722526 ↗
• InjuryMay 11, 2020Component Incompatible; Component Incompatible

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9616096-2020-00001 FOR THE FIRST PATIENT. REFER TO 9616096-2020-00003 FOR THE THIRD PATIENT. IT WAS REPORTED THAT STAFF MEMBERS HAD AN REACTION AND REPORTED RESPIRATORY DISTRESS TO EMPLOYEE HEALTH DURING USE WEARING AN (UNKNOWN PRODUCT NUMBER) YELLOW PROCEDURE MASK. ADDITIONAL INFORMATION WAS RECEIVED ON 23-APRIL-2020 THAT STATES THE PRODUCT CODE IDENTIFIED WAS 47117 AND LOT NUMBER LOT: AM0073101. IT WAS REPORTED THAT 3 HAVE EMPLOYEES REPORTED TO EMPLOYEE HEALTH FOR ITCHING, BURNING, TO RASHES, DIFFICULTY BREATHING AND AN EMPLOYEE USED BENADRYL. THE EMPLOYEES CHANGED THE MASK TO AFTER HAVING A REACTION. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APRIL-2020 THAT STATES (2) FACILITIES LISTED FOR THIS COMPLAINT (B)(6) MEDICAL CENTER, DIFFERENT ADDRESSES, SAME ALERT DATE AND STOCK CODES. ADDITIONAL INFORMATION WAS RECEIVED ON 28-APRIL-2020 THAT STATES THE DURATION OF USE WEARING THE MASK WAS BETWEEN 5 MINUTES TO 8-12 HOURS. THERE WAS NO MEDICAL INTERVENTION PROVIDED AND THE ISSU

  Patient problems: Reaction

  MAUDE report 10044246 ↗
• InjuryMay 5, 2020Component Incompatible; Component Incompatible

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9616096-2020-00001 FOR THE FIRST PATIENT. REFER TO 9616096-2020-00002 FOR THE SECOND PATIENT. IT WAS REPORTED THAT STAFF MEMBERS HAD A REACTION AND REPORTED RESPIRATORY DISTRESS TO EMPLOYEE HEALTH DURING USE WEARING AN (UNKNOWN PRODUCT NUMBER) YELLOW PROCEDURE MASK. ADDITIONAL INFORMATION WAS RECEIVED ON 23-APRIL-2020 THAT STATES THE PRODUCT CODE IDENTIFIED WAS 47117 AND LOT NUMBER LOT: AM0073101. IT WAS REPORTED THAT 3 HAVE EMPLOYEES REPORTED TO EMPLOYEE HEALTH FOR ITCHING, BURNING, TO RASHES, DIFFICULTY BREATHING, AND AN EMPLOYEE USED BENADRYL. THE EMPLOYEES CHANGED THE MASK TO AFTER HAVING A REACTION. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APRIL-2020 THAT STATES (2) FACILITIES LISTED FOR THIS COMPLAINT (B)(6) MEDICAL CENTER, DIFFERENT ADDRESSES, SAME ALERT DATE AND STOCK CODES. ADDITIONAL INFORMATION WAS RECEIVED ON 28-APRIL-2020 THAT STATES THE DURATION OF USE WEARING THE MASK WAS BETWEEN 5 MINUTES TO 8-12 HOURS. THERE WAS NO MEDICAL INTERVENTION PROVIDED AND THE ISSU

  Patient problems: Reaction

  MAUDE report 10024154 ↗
• InjuryMay 5, 2020Component Incompatible; Component Incompatible

  O&M HALYARD, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9616096-2020-00002 FOR THE SECOND PATIENT. REFER TO 9616096-2020-00003 FOR THE THIRD PATIENT. IT WAS REPORTED THAT STAFF MEMBERS HAD A REACTION AND REPORTED RESPIRATORY DISTRESS TO EMPLOYEE HEALTH DURING USE WEARING AN (UNKNOWN PRODUCT NUMBER) YELLOW PROCEDURE MASK. ADDITIONAL INFORMATION WAS RECEIVED ON 23-APRIL-2020 THAT STATES THE PRODUCT CODE IDENTIFIED WAS 47117 AND LOT NUMBER LOT: AM0073101. IT WAS REPORTED THAT 3 HAVE EMPLOYEES REPORTED TO EMPLOYEE HEALTH FOR ITCHING, BURNING, TO RASHES, DIFFICULTY BREATHING, AND AN EMPLOYEE USED BENADRYL. THE EMPLOYEES CHANGED THE MASK TO AFTER HAVING A REACTION. ADDITIONAL INFORMATION WAS RECEIVED ON 24-APRIL-2020 THAT STATES (2) FACILITIES LISTED FOR THIS COMPLAINT (B)(6) MEDICAL CENTER, DIFFERENT ADDRESSES, SAME ALERT DATE AND STOCK CODES. ADDITIONAL INFORMATION WAS RECEIVED ON 28-APRIL-2020 THAT STATES THE DURATION OF USE WEARING THE MASK WAS BETWEEN 5 MINUTES TO 8-12 HOURS. THERE WAS NO MEDICAL INTERVENTION PROVIDED AND THE ISSU

  Patient problems: Reaction

  MAUDE report 10024149 ↗
• InjurySep 21, 2018Component Incompatible; Component Incompatible

  IT WAS REPORTED BY THE CUSTOMER WHO STATED THAT SHE EXPERIENCED AN ASTHMA ATTACK ON HOUR INTO WEARING THE MASK. THE CUSTOMER STATED THAT SHE EXPERIENCED SHORTNESS OF BREATH, RR 16 BPM, HR 120, SATURATION OF 96%, AND WELTS ON HER FACE. SHE WAS TAKEN TO THE EMERGENCY ROOM AT WORK AND TREATED WITH ALBUTEROL, THEN LEVALBUTEROL. THE CUSTOMER HAS HAD ALLERY TESTING AND IS ALLERGIC TO ALBUTEROL POLYESTER, NUTS, LATEX, GRASS, AND TREES. AFTER THE LEVALBUTEROL TREATMENT THE CUSTOMER'S SUMPTOMS RESOLVED, THE NEXT DAY THE CUSTOMER ALSO TOOK ANOTHER INHALER MDI TREATMENT AND A NECULIZER OF LEVALBUTEROL. THE CUSTOMER STATE THAT SHE TAKES BENADRYL PRN OR AS NEEDED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 7897944 ↗
• InjuryJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER WHO STATED, A STAFF MEMBER EXPERIENCED AN ANAPHYLACTIC REACTION WHILE WEARING THE MASK. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 FROM THE DISTRIBUTOR THAT STATES, "LAST WEEK THEY HAD AN EMPLOYEE THAT HAD A REACTION TO THE MASK". ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2018 FROM THE HR GENERALIST THAT STATED, THE INDIVIDUAL REPORTED THAT HER, ¿THROAT STARTED CLOSING UP¿ AND SHE WENT TO THE ED (EMERGENCY DEPARTMENT) FOR TREATMENT. THE EVENT INVOLVED RESPIRATORY DISTRESS AND MEDICAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018 BY EMAIL THAT STATED,"I HAD BEEN WEARING THE MASK SINCE I ARRIVED AT 12:00 PM. YES, I HAD BEEN WEARING THE MASK FOR A COUPLE OF WEEKS. THERE HAVE BEEN NO KNOWN ALLERGIES, AND HAVE NOT TAKEN MEDICATIONS FOR ALLERGIES. WHEN I WAS IN THE EMERGENCY ROOM THEY GAVE ME A STEROID TREATMENT; HOWEVER, I'M NOT SURE WHAT THE NAME OF THE MEDICATION WAS. THE REACTION WAS RESOLVED BY DISCONTINUING WEARING THE MASK, AND TAKING THE STEROIDS PRESCRIBED BY THE EMERGENCY ROOM DOCTOR, AND WEARING A DIFFERENT MASK. I HAVE NOT

  Patient problems: Reaction; Respiratory Distress

  MAUDE report 7226556 ↗