AIRSEALRecalls & reported problems across all models

We found 15 models of AIRSEAL by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 236 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2020 and Jul 20, 2026 — classified as 4 deaths, 56 injuries, 176 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (108 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 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

AIRSEAL 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. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2474-2026 · Root cause: Process change control · Recall details · FDA record ↗

2. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2473-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2472-2026 · Root cause: Process change control · Recall details · FDA record ↗

4. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2471-2026 · Root cause: Process change control · Recall details · FDA record ↗

5. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2470-2026 · Root cause: Process change control · Recall details · FDA record ↗

6. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2469-2026 · Root cause: Process change control · Recall details · FDA record ↗

7. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2468-2026 · Root cause: Process change control · Recall details · FDA record ↗

8. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2467-2026 · Root cause: Process change control · Recall details · FDA record ↗

9. May 14, 2026Open, Classified

   Potential for overpressure alerts.

   Z-2466-2026 · Root cause: Process change control · Recall details · FDA record ↗

10. May 14, 2026Open, Classified

    Potential for overpressure alerts.

    Z-2465-2026 · Root cause: Process change control · Recall details · FDA record ↗

11. May 14, 2026Open, Classified

    Potential for overpressure alerts.

    Z-2464-2026 · Root cause: Process change control · Recall details · FDA record ↗

Most reported AIRSEAL problems

AIRSEAL models

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

• AIRSEAL IAS12-100LPI

  Laparoscope, general & plastic surgery
  1 recall68 reports
• AIRSEAL IAS5-120LP

  Laparoscope, general & plastic surgery
  2 recalls4 reports
• AIRSEAL AS-iFS1

  Insufflator, laparoscopic
  4 deaths93 reports
• AIRSEAL IAS12-120LPI

  Laparoscope, general & plastic surgery
  1 recall19 reports
• AIRSEAL IAS8-100LP

  Laparoscope, general & plastic surgery
  1 recall8 reports
• AIRSEAL IAS5-100LP

  Laparoscope, general & plastic surgery
  1 recall5 reports
• AIRSEAL IAS12-150LPi

  Laparoscope, general & plastic surgery
  1 recall5 reports
• AIRSEAL IASB5-150

  Laparoscope, general & plastic surgery
  1 recall0 reports
• AIRSEAL IASB12-120

  Laparoscope, general & plastic surgery
  1 recall0 reports
• AIRSEAL IAS5-75LP

  Laparoscope, general & plastic surgery
  1 recall0 reports
• AIRSEAL IASB12-120

  Laparoscope, general & plastic surgery
  1 recall0 reports
• AIRSEAL IAS8-120LP

  Laparoscope, general & plastic surgery
  23 reports
• AIRSEAL ASM-EVAC1

  INSUFFLATOR, LAPAROSCOPIC
  5 reports
• AIRSEAL AS-IFS2

  Insufflator, laparoscopic
  5 reports
• AIRSEAL IASB12-100

  Laparoscope, general & plastic surgery
  1 report

Recent AIRSEAL adverse event reports

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

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿SUBCUTANEOUS EMPHYSEMA OCCURRED.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF MALFUNCTION FOR ANY CONMED DEVICE. AN IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP AND AN ASM-EVAC1, TRI-LUMEN FILTERED TUBE SET WITH ACTIVATED CHARCOAL FILTER, WERE ALSO USED IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT DEVELOPING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25870312 ↗
• MalfunctionJul 15, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25824776 ↗
• MalfunctionJul 10, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25777499 ↗
• MalfunctionJun 17, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS12-100LPI 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP, WAS BEING USED DURING A ROBOT-ASSISTED GASTRIC PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿THE BLUE PORTION OF THE SOUND REDUCTION CAP CAUGHT ON FORCEPS AND WAS DAMAGED, AND A FRAGMENT FELL INTO THE ABDOMINAL CAVITY; HOWEVER, IT WAS SUCCESSFULLY RETRIEVED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534267 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT (B)(6) HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476692 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT U OF R HIGHLAND HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476657 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT U OF R HIGHLAND HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476654 ↗
• InjuryMay 28, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE IAS5-120LP, 5 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 2026 DURING A HYSTERECTOMY AND THE ¿CANNULA BROKE MIDWAY UP TO THE SHAFT OUTER LUMEN CRACKED WITH SMALL 2X8 PIECE MISSING. MISSING PIECE COULD NOT BE LOCATED. X-RAY TAKEN WITHOUT IDENTIFICATION OF PIECE IN PATIENT ABDOMEN.¿ PER FURTHER ASSESSMENT IT WAS REPORTED "WE CANNOT CONFIRM WHETHER OR NOT THE FRAGMENT OF THE CANNULA WAS RETAINED OR NOT RETAINED WITHIN THE PATIENT. A KUB INTRAOPERATIVE X-RAY WAS TAKEN IN AN ATTEMPT TO LOCATE THE FRAGMENT. HOWEVER, CONFIDENCE WAS LOW FOR SEEING THE FRAGMENT ON RADIOGRAPHY DUE TO THE LACK OF OR LIMITED RADIOPACITY OF THE MATERIAL AND SMALL SIZE OF THE FRAGMENT. THE PIECE COULD POSSIBLY HAVE BEEN RETAINED." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS A 60 TO 90-MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT COULD POSSIBLY HAVE RETAINED A DEVICE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25316322 ↗
• MalfunctionMay 15, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS5-100LP, 5 MM ACCESS PORT & LOW PROFILE OBTURATOR DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2026, AND ¿DURING THE OPERATION, THE PUNCTURE DEVICE BROKE AND FELL INTO THE BODY. THE ENTIRE SET HAD TO BE REPLACED.¿. FURTHER ASSESSMENT FOUND "THE TROCAR BROKE IN THE PATIENT" AND ALL FRAGMENTS WERE RETRIEVED BY HAND.". THE ASM-EVAC1 DEVICE DID NOT FRAGMENT OR FALL INTO THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185389 ↗
• MalfunctionMay 15, 2026Gas Output Problem; Output Problem

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MAUDE REPORT(B)(4) ON 05MAY26. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE AS-IFS1 AIRSEAL IFS, 120V DEVICE THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2026. THE REPORT STATED, ¿LOSS OF AIRSEAL SUDDENLY DURING PROCEDURE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183717 ↗
• MalfunctionMay 14, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS5-100LP, 5 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 26 AND ¿DURING SURGERY, THE DOUBLE CHAMBER OF THE 5 MM AIRSEAL TROCAR BROKE AND WE FOUND IT IN THE ABDOMINAL CAVITY.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT. PER FURTHER ASSESSMENT IT WAS REPORTED THAT THE TROCAR FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS A 2-MINUTE DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169890 ↗
• MalfunctionMay 7, 2026Loss of Power

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN AN UNNAMED PROCEDURE ON AN UNKNOWN DATE, AND ¿THE DEVICE SHUT DOWN DURING STARTUP.¿. ADDITIONAL INFORMATION INDICATED "REGARDING THE USE OF THE TERM ¿DURING STARTUP¿ IN THE INITIAL REPORT, THIS WAS DUE TO A MISTRANSLATION WHEN WE TRANSLATED THE ORIGINAL JAPANESE EXPRESSION ¿XXX¿ INTO ENGLISH. IN THIS CASE, ¿XXX¿ WAS INTENDED TO MEAN THAT THE DEVICE WAS OPERATING WHILE USING AIRSEAL, RATHER THAN THE INITIAL SYSTEM STARTUP PHASE." FURTHER ASSESSMENT FOUND THAT PNEUMOPERITONEUM HAD BEEN FULLY ESTABLISHED AND WAS LOST SUDDENLY WHEN THE DEVICE SHUT DOWN." THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110134 ↗
• MalfunctionMay 6, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2026, AND ¿THE VALVE OF THE AIRSEAL TROCAR SOUND CAP WAS DAMAGED, SO ITS USE WAS DISCONTINUED AND THE ENTIRE TROCAR WAS REPLACED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT FOUND "THE INFORMATION IS VERY LIMITED, BUT THE FRAGMENT DID NOT FALL INTO THE SURGICAL SITE". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093094 ↗
• MalfunctionMay 1, 2026Loss of Power

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS2, AIRSEAL IFS, 230V DEVICE WAS USED IN A ROBOTIC SURGERY WITH THE DA VINCI XI SURGICAL SYSTEM GASTRECTOMY ON (B)(6) 2026, AND ¿SUDDENLY DURING THE PROCEDURE, WITHOUT ANY SPECIFIC ACTION OR CHANGE IN USAGE, THE AIRSEAL UNIT SHUT DOWN. WHEN ATTEMPTING TO RESTART, THE DISPLAY SHOWED THE ERROR MESSAGE: ¿ELECTRONIC ERROR! RESTART THE DEVICE AND CONTACT SERVICE.¿ THE UNIT WAS RESTARTED, BUT THE SAME ERROR MESSAGE REAPPEARED. THE DEVICE WAS RESTARTED AGAIN WITH THE SAME RESULT. A DIFFERENT AIRSEAL UNIT WAS THEN BROUGHT IN AND CONNECTED USING THE SAME TUBING SET AND PORT. THE REPLACEMENT UNIT FUNCTIONED NORMALLY, AND THE PROCEDURE COULD CONTINUE AS PLANNED. THE AIRSEAL SYSTEM WAS USED IN AIRSEAL MODE WITH AN AIRSEAL TUBING SET AND PORT.¿ FURTHER ASSESSMENT FOUND, "THE GAS LOSS MUST HAVE OCCURRED SUDDENLY. AT THE SAME TIME, IT IS ALWAYS DIFFICULT TO ASSESS EXACTLY HOW THE PROCESS OCCURRED IN RETROSPECT, BUT IN THAT CASE, THEY DID NOT HAVE TIME TO REMOVE THE INSTRUMENTS. HOWEVER, THERE WAS NOT ANY DAMAGE DONE." THE PROCEDURE WAS COMPLETED WITH A DELAY OF 5 MINUTES. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION, OR E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058148 ↗
• MalfunctionApr 28, 2026Power Problem

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND ¿THE POWER WENT OUT DURING THE OPERATION, AND AFTERWARDS THERE WAS A BURNING SMELL. THE SURGERY WAS THEN CONTINUED AFTER REPLACING IT WITH ANOTHER AIR SEAL.¿. FURTHER ASSESSMENT FOUND ¿THE DEVICE WAS SHUT DOWN SUDDENLY, AND THERE WAS NO ALARM. THE PNEUMO WAS LOST¿ SUDDENLY. THE PROCEDURE WAS COMPLETED, WITH NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015453 ↗

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