Z-2465-2026Class II

ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6...

Name: Z-2465-2026 ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6...
Creator: ConMed Corporation
Published: 2026-05-14
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2026-05-14 / Open, Classified

FDA source

ConMed Corporation began a recall of ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and... on 2026-05-14. FDA classified it as Class II and gives the reason as "Potential for overpressure alerts". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2465-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-14
Posted: 2026-06-17
Recalling firm: ConMed Corporation
Product: ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Potential for overpressure alerts.
FDA root cause: Process change control
Action: ConMed notified consignees on about 05/14/2026 via emailed and mailed letter titled URGENT: Medical Device Correction. Consignees were made aware of the issue and risk associated with the issue. They were instructed that a replacement AirSeal disposable should be available prior to procedures in order to minimize potential delays. Before initiating insufflation, the user should ensure the tubing is properly connected between the AirSeal tube set and Airseal Access Ports. If the connection cannot be securely tightened and the overpressure alert cannot be resolved, please replace the affected device. Detailed instructions were provided on how to connect the AirSeal tube set and Airseal Access Ports. Consignees were also instructed to review inventory for affected units, place a copy of the provided Instructions for Use, Part No. AS-DIS-IFU, Rev. B with any inventory in possession with an active expiration date, contact all applicable departments and facilities that may have received affected products for awareness, and complete and return the medical device response form. If further information relevant to this issue becomes necessary CONMED will communicate as such. On about 06/04/2026 ConMed expanded their recall to include internationally distributed units. The letter sent included the same instructions.
Quantity in commerce: 891 packs (5,346 eaches)
Distribution: Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .
Product codes and lots: Catalog Number: iASB12-120. UDI-DI: 10845854045725. Lot Numbers: 202507314, 202506194, 202510024, 202501165, 202504034, 202408225, 202411264. *OUS added 06/10/2026 expansion: 202510024, 202507314, 202504034, 202501165, 202411264, 202408225, 202506194. Manufactured from 14 June 2024 to 12 January 2026.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2465-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2464-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2465-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2466-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2467-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2468-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2469-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2470-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2471-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2472-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2473-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17
Z-2474-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-17

Product code HIF

K143404Class IISurgiQuest AirSeal iFS SystemSurgiquest, Inc. / cleared 2015-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)