Vital SignsRecalls & reported problems across all models

We found 48 models of Vital Signs by Airlife in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Feb 3, 2020 and Aug 5, 2026 — classified as 27 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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. 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

Most reported Vital Signs problems

Vital Signs models

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

• Vital Signs™ B1714XXX

  Circuit, breathing (w connector, adaptor, y piece)
  8 reports
• Vital Signs™ A4FX2004

  Ventilator, emergency, manual (resuscitator)
  4 reports
• Vital Signs™ AFNXXXXX

  Circuit, breathing (w connector, adaptor, y piece)
  4 reports
• Vital Signs™ AFPXXXXX

  Circuit, breathing (w connector, adaptor, y piece)
  4 reports
• Vital Signs™ AMY520X4F

  Ventilator, emergency, manual (resuscitator)
  4 reports
• Vital Signs™ IN800012

  INFUSOR, PRESSURE, FOR I.V. BAGS
  3 reports
• Vital Signs™ 1552016

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  3 reports
• Vital Signs™ 5037AE

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ 5108EX

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ A4U12214

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ A5U580A4

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ ADU320X4D

  Ventilator, emergency, manual (resuscitator)
  2 reports
• Vital Signs™ ADU520X4D

  Ventilator, emergency, manual (resuscitator)
  2 reports
• Vital Signs™ AFN52004

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ AFNX1900

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ AFRXXXXX

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ AMN520X4F

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ AXXXXX61

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ B1513XXX

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ GK7FXXXX

  Ventilator, emergency, manual (resuscitator)
  2 reports
• Vital Signs™ 6810EU

  Circuit, breathing (w connector, adaptor, y piece)
  2 reports
• Vital Signs™ S5000N

  STYLET, TRACHEAL TUBE
  2 reports
• Vital Signs™ 5503EU

  VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  1 report
• Vital Signs™ A1UXOXXX

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ A4UX2044

  Ventilator, emergency, manual (resuscitator)
  1 report
• Vital Signs™ A4UX2XXX

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ A4Y580X4F

  Ventilator, emergency, manual (resuscitator)
  1 report
• Vital Signs™ A8UB20X4

  Ventilator, emergency, manual (resuscitator)
  1 report
• Vital Signs™ ADU52914

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AFN52024

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AFN52XX4

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AFN580AC

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AFNX2004

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AGNX2XXX

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ AZFCX7XXX

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ B1717XXX

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ B1734XX4

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ B1754XT4

  Circuit, breathing (w connector, adaptor, y piece)
  1 report
• Vital Signs™ GLIXXXXX

  Anesthesia breathing circuit kit (adult & pediatric)
  1 report
• Vital Signs™ 4556EU

  Laryngoscope, Rigid
  1 report
• Vital Signs™ 1552017

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• Vital Signs™ 5210

  Mask, Gas, Anesthetic
  1 report
• Vital Signs™ 54039VS

  Ventilator, Non-Continuous (Respirator)
  1 report
• Vital Signs™ A4F52014

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• Vital Signs™ A4UX2XXX

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• Vital Signs™ A4YX2XX4D

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• Vital Signs™ AMN520X4F

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report
• Vital Signs™ AMY520X4F

  Circuit, Breathing (W Connector, Adaptor, Y Piece)
  1 report

Recent Vital Signs adverse event reports

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

• MalfunctionAug 5, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150104 ↗
• MalfunctionJun 23, 2026Unintended Movement

  ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 1314417-2026-00042 FOR THE FIRST REPORT. REFER TO 1314417-2026-00043 FOR THE SECOND REPORT. REFER TO 1314417-2026-00044 FOR THE THIRD REPORT. IT WAS REPORTED, THAT THE CONNECTION CAME APART ON THE ADULT ANESTHESIA CIRCUIT DUE TO THE RUBBER BAND SOMEHOW STARTED TO ROLL UP DUE TO EXTERNAL PRESSURE. IT WAS ADDITIONALLY REPORTED, THE MEDICAL STAFF ACTED QUICKLY, THE TUBE WAS REPLACED, AND NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602608 ↗
• MalfunctionJun 23, 2026Unintended Movement

  ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 1314417-2026-00042 FOR THE FIRST REPORT. REFER TO 1314417-2026-00043 FOR THE SECOND REPORT. REFER TO 1314417-2026-00044 FOR THE THIRD REPORT. IT WAS REPORTED, THAT THE CONNECTION CAME APART ON THE ADULT ANESTHESIA CIRCUIT DUE TO THE RUBBER BAND SHIFTING BACKWARDS. IT WAS ADDITIONALLY REPORTED, THE MEDICAL STAFF ACTED QUICKLY, THE TUBE WAS REPLACED, AND NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602607 ↗
• MalfunctionJun 1, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE LIMB-O TUBING ON THE MAIN LIMB, ASSOCIATED WITH A PATIENT EVENT INVOLVING OXYGEN DESATURATION. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S OUTCOME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25355233 ↗
• MalfunctionApr 3, 2026Gas/Air Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, WHILE PREPARING TO TRANSFER THE PATIENT TO THE NICU, A FLOW INFLATING RESUSCITATION (FIR) DEVICE WAS CONNECTED TO THE OXYGEN TANK. UPON ACTIVATION, THE PATIENT BEGAN TO DESATURATE. THE ANESTHESIOLOGIST OBSERVED THAT THE DEVICE WAS LEAKING OXYGEN THROUGH A HOLE, RESULTING IN INEFFECTIVE OXYGEN DELIVERY. THE ANESTHESIOLOGIST PROMPTLY RECONNECTED THE ANESTHESIA MACHINE, PROVIDED APPROPRIATE OXYGEN, AND STABILIZED THE PATIENT. A NEW FIR DEVICE WAS THEN OBTAINED AND CONNECTED, ALLOWING THE TEAM TO PROCEED WITH THE TRANSFER. NO SERIOUS HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24776337 ↗
• MalfunctionFeb 12, 2026Failure to Seal

  IT WAS REPORTED THAT THE FACE MASK LOSES AIR AT THE SEAL OVER TIME. THESE MASKS ARE USED TO VENTILATE PATIENTS WITH EITHER THE NEO TEE OR AMBU BAGS, AND WHEN DEFLATED, THEY FAIL TO MAINTAIN AN ADEQUATE SEAL AND MAY CAUSE SKIN INJURY. NO INJURY WAS REPORTED, AND THERE WAS NO REPORT OF ANY DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328531 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT THE CIRCUIT WAS EXHIBITING A LEAK, AND THE BLUE CAPS WERE COMING LOOSE FROM THE CORRUGATED CIRCUIT COMPONENT. A NON-SERIOUS INJURY WAS NOTED; HOWEVER, NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24076480 ↗
• MalfunctionJan 8, 2026Material Rupture

  IT WAS REPORTED THAT THE ANESTHESIOLOGIST DISCOVERED THE MANUAL VENTILATION BAG WAS RUPTURED APPROXIMATELY ONE HOUR AFTER USE BEGAN. MANUAL VENTILATION WAS NOT BEING PERFORMED AT THE TIME OF DISCOVERY. THE PATIENT'S HEALTH STATUS REMAINED STABLE, WITH NO REPORTED ISSUES. THERE WAS NO DELAY IN THERAPY, AND NO HARM OR INJURY RESULTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012988 ↗
• InjuryJan 1, 2026Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. 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 1314417-2026-00002 FOR THE SECOND REPORT. REFER TO 2028807-2026-00001 FOR THE THIRD REPORT. IT WAS REPORTED, THE CIRCUIT DISCONNECTED MULTIPLE TIMES, WHICH HAS RESULTED IN THE PATIENT DESATURATING, DOWN INTO THE 60S. NO INFORMATION WAS PROVIDED CONCERNING MEDICAL INTERVENTION OR PATIENT OUTCOME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23940762 ↗
• InjuryJan 1, 2026Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. 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 1314417-2026-00001 FOR THE FIRST REPORT. REFER TO 2028807-2026-00001 FOR THE THIRD REPORT. IT WAS REPORTED, THE CIRCUIT DISCONNECTED MULTIPLE TIMES, WHICH HAS RESULTED IN THE PATIENT DESATURATING, DOWN INTO THE 60S. NO INFORMATION WAS PROVIDED CONCERNING MEDICAL INTERVENTION OR PATIENT OUTCOME.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23940761 ↗
• MalfunctionDec 12, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT TWO BAGS IN THE CIRCUIT KITS EXPLODED DURING ANESTHESIA.

  Patient problems: Respiratory Arrest

  MAUDE report 23796516 ↗
• MalfunctionOct 3, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE CIRCUIT HAS DETACHED AT THE Y/CIRCUIT MULTIPLE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23216324 ↗
• MalfunctionSep 11, 2025Partial Blockage; No Device Output; Failure to Deliver; Blocked Connection; No Flow; Partial Blockage; No Device Output; Failure to Deliver; Blocked Connection; No Flow

  IT WAS REPORTED THAT DURING PROCEDURE THE HME PORT WAS OCCLUDED. WHILE NO HARM OR INJURY WAS REPORTED TO THE PATIENT IF THIS WERE TO REOCCUR THE PATIENT COULD BECOME HYPOXIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032572 ↗
• MalfunctionAug 29, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE THE PATIENT SHOWED HIGH PEEP WITH LOW TIDAL VOLUME, MAKING IT DIFFICULT FOR PRACTITIONERS TO PROPERLY VENTILATE THE PATIENT. IN SOME CASES, THEY REMOVED THE CIRCUIT AND USED AN AMBU BAG, SUCCESSFULLY VENTILATING THE PATIENT. THE HME OCCLUDED DURING USE AND DID NOT ALLOW ANY AIR TO PASS THROUGH IT. THE HME BECAME A BRICK WALL AT THE FILTER. WHILE THERE WAS NO REPORTED INJURY TO THE PATIENT IF IT WERE TO REOCCUR, THERE IS A POSSIBILITY OF SERIOUS HARM OR INJURY TO THE PATIENT AND A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929347 ↗
• MalfunctionAug 6, 2025Blocked Connection; Incomplete or Inadequate Connection; Blocked Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT IMMEDIATELY AFTER INDUCTION OF GENERAL ANESTHESIA, THE INTUBATION TUBE WAS CONNECTED TO THE CIRCUIT AND THE VENTILATION RATER WAS LESS THAN 100 ML. WHILE THERE WAS NO HARM OR INJURY REPORTED, BASED ON THE INFORMATION PROVIDED. THE DECREASE IN VENTILATION COULD DELAY PATIENT THERAPY EVEN THOUGH VBM WAS USED AND THE PATIENT VS STABILIZED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22733076 ↗

Other Airlife products

• BROSELOW4 models · 0 reports · 5 recalls
• SuperNO2VA5 models · 19 reports · 1 recall
• Air-Q32 models · 1 reports · 1 recall