Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36881 |
| Brand Name: | AirSeal® iFS Access Port with Trocar |
| Model: | |
| Affected: | Catalogue number - iASB5-150, iASB12-120, iASB12-100, iAS8-120LP, iAS8-100LP, iAS5-75LP, iAS5-120LP, iAS5-100LP, iAS12-150LPI, iAS12-120LPI, iAS12-100LPI |
| Software version: | |
| Recalling Organisation: | Paragon Care Group New Zealand Limited 69 Elizabeth Knox Place Glen Innes AUCKLAND |
| Contact Information: | 0508 654 258 |
| Manufacturer: | ConMed Corporation |
| Issue: | The manufacturer has received an increase in reports of overpressure alerts with AirSeal Access Ports, which in some cases have resulted in delay of treatment. During a review of complaint data, the manufacturer identified that a previous manufacturing process update may, under certain conditions, contribute to overpressure alerts. In response, the Instructions for Use (IFU) have been clarified to ensure proper device tightening. In the event of an overpressure condition, AirSeal® is designed to respond automatically via a built-in venting system, which activates when the pressure exceeds the set point by more than 3 mm Hg for more than 3 seconds. When there is improper device tightening, the overpressure alert may be erroneous, representing a higher-than-expected pressure within the system between the AirSeal® iFS and the AirSeal® access port but not a higher-than-expected pressure within the patient. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/6/2026 |
