SuperNO2VARecalls & reported problems across all models

We found 5 models of SuperNO2VA by Airlife in the FDA's device registry (GUDID). Together they are named in 19 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2020 and Jan 22, 2026 — classified as 1 injury, 18 malfunctions.

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

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SuperNO2VA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 11, 2023Open, Classified

   A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

   Z-0363-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported SuperNO2VA problems

SuperNO2VA models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SuperNO2VA SSL-20

  Cardiopulmonary Resuscitation Aid Kit
  1 recall0 reports
• SuperNO2VA SSL-20

  Cardiopulmonary resuscitation aid kit
  9 reports
• SuperNO2VA SSM-20

  Cardiopulmonary resuscitation aid kit
  7 reports
• SuperNO2VA SSM-20

  Cardiopulmonary Resuscitation Aid Kit
  2 reports
• SuperNO2VA SSEM-20

  Cardiopulmonary Resuscitation Aid Kit
  1 report

Recent SuperNO2VA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Gas/Air Leak

  IT WAS REPORTED THAT SMALL TEARS ALONG THE CREASE OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158007 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT; REFER TO 1314417-2025-00033 FOR THE SECOND REPORT; REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081878 ↗
• InjuryMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT, REFER TO 1314417-2025-00034 FOR THE THIRD REPORT, REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081877 ↗
• MalfunctionMay 23, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 1314417-2025-00032 FOR THE FIRST REPORT. REFER TO 1314417-2025-00033 FOR THE SECOND REPORT. REFER TO 1314417-2025-00034 FOR THE THIRD REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081876 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 1314417-2025-00033 FOR THE SECOND REPORT. REFER TO 1314417-2025-00034 FOR THE THIRD REPORT. REFER TO 1314417-2025-00035 FOR THE FOURTH REPORT. IT WAS REPORTED, DURING USE HOLE(S) WERE DISCOVERED IN THE GREEN BAG. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081875 ↗
• MalfunctionFeb 20, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WAS 3 INCIDENTS WITH THIS PRODUCT , OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE THRID REPORT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424033 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WAS 3 INCIDENTS WITH THIS PRODUCT , OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE SECOND REPORT IS 8030673-2025-00004.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264336 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH (B)(6), OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WERE 3 INCIDENTS WITH THIS PRODUCT, OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORTS. THE FIRST REPORT NUMBER IS 8030673-2022-00004, AND THE THIRD REPORT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264335 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT HAS BEEN REPORTED THAT: I WAS SPEAKING WITH TIFFANY GUINTHER, OR MANAGER, AND SHE SAID THE STRAP FROM THE MASK WAS BREAKING. I WILL CLARIFY AS TO THE EXACT NUMBER OF INSTANCES THIS OCCURRED. IT WAS FOUND THAT THERE WERE 3 INCIDENTS WITH THIS PRODUCT, OF WHICH WILL BE REPORTED ON 3 DIFFERENT REPORS. THE SECOND REPORT NUMBER IS 8030673-2022-00005, AND THE THRID REPORTT IS 8030673-2025-00006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264334 ↗
• MalfunctionJun 20, 2022Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT THE SSL-20-SUPERNOVA NASAL PAP VENTILATION SYSTEM(LARGE) 50-R3439-07 WAS USED DURING AN UPPER ENDOSCOPY. THE DEVICE WAS DEFECTIVE, HAD MULTIPLE HOLES AT THE END OF THE BAG AND THE COLOR FADED. THE DEVICE WAS KEPT AWAY. ACCORDING TO THE CRNA AND ANESTHESIOLOGIST, THE SAME ISSUE HAPPENED BEFORE. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750320 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266426 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266412 ↗
• MalfunctionJan 17, 2022Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE ELASTIC BAG DESIGNED TO MANUALLY ASSIST BREATHING HAD MULTIPLE HOLES FORMED AT THE FOLDED SEAMS OF THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266402 ↗
• MalfunctionAug 25, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE CUSTOMER REPORTED THAT THE SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) EXPERIENCED TEAR IN THE BAG DURING SETUP. THE FIRST OPTION WAS TO SWITCH THE BAG BUT THE CRNA OPTED TO PUT TAPE OVER THE TEAR IN THE BAG. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366181 ↗
• MalfunctionMay 11, 2021Misassembled; Misassembled

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ABS BAG ARM CONNECTOR ELBOW OF SUPERNOVA NASAL PAP VENTILATION SYSTEM WAS PUT ON BACKWARDS NOT ALLOWING IT TO CONNECT TO THE ANESTHESIA MACHINE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807424 ↗

Other Airlife products

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