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AIRSEAL recallZ-2470-2026 · ConMed Corporation · initiated May 14, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from ConMed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for overpressure alerts.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-2470-2026
Status
Open, Classified
Initiated by the company
May 14, 2026
Posted by the FDA
Jun 17, 2026
Recalling firm
ConMed Corporation
Quantity
32,792 packs (196,751 eaches)
Product code
HIF
FDA submissions
K143404
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 description

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

Catalog Number: iAS5-120LP. UDI-DI: 10845854045657. Lot Numbers: 202504214, 202511075, 202510254, 202510274, 202510244, 202511104, 202601084, 202506054, 202506114, 202506104, 202505164, 202505294, 202505154, 202505176, 202507174, 202507184, 202507214, 202507044, 202506244, 202507024, 202507034, 202510024, 202510104, 202509194, 202507314, 202508134, 202508144, 202509224, 202509164, 202508294, 202509084, 202507315, 202507294, 202410094, 202410254, 202411114, 202409254, 202409255, 202505014, 202504224, 202502174, 202502254, 202504034, 202408234, 202501145, 202412124, 202408305, 202511064, 202510234, 202409114, 202409126, 202410174, 202510084, 202407105, 202502115, 202411194, 202508154, 202502134, 202502145, 202501174, 202510074, 202509094, 202505054, 202508014, 202506094, 202506174, 202506164, 202511065, 202601094, 202406245, 202409146, 202501316, 202502044, 202501154, 202502016, 202501155, 202501024, 202502245, 202503245, 202503266, 202503244, 202504044, 202504046, 202504164, 202407195, 202408235, 202407104, 202407224, 202410244, 202411074, 202412054, 202508274, 202501304, 202501144, 202504025, 202502135, 202501315, 202501295, 202504304, 202408225, 202409115, 202502045, 202504305, 202509014, 202509154, 202410165, 202408054, 202412174, 202412055, 202502126, 202501035, 202409135, 202507304, 202508284, 202409124, 202501305, 202410075, 202409125, 202502244, 202412165, 202501025, 202502156, 202511076, 202411075, 202510014, 202408024, 202412064, 202409264, 202411195, 202504174, 202412175, 202411084, 202509204, 202510114, 202412234, 202409136, 202409134, 202408145, 202409256, 202411085, 202601074, 202501306, 202409024, 202510284, 202406244, 202408015, 202502256, 202506234, 202503074, 202408124, 202502056, 202407024, 202412184, 202410245, 202410255, 202410104, 202409275, 202408144, 202409116. *OUS added 06/10/2026 expansion: 202407015, 202506104, 202501024, 202510244, 202511104, 202510274, 202508144, 202510024, 202510104, 202507034, 202507184, 202505054, 202505164, 202506244, 202412064, 202412184, 202408025, 202510254, 202507314, 202507044, 202503244, 202409256, 202509154, 202507315, 202506174, 202510074, 202412175, 202501305, 202504034, 202505154, 202407224, 202407105, 202505014, 202501316, 202502245, 202511065, 202409254, 202411194, 202410254, 202409114, 202511075, 202507214, 202407104, 202601084, 202412054, 202509164, 202504305, 202505294, 202408225, 202407024, 202509084, 202504304, 202502115, 202408054, 202509014, 202410255, 202601094, 202409125, 202408015, 202406245, 202510014, 202410245, 202501315, 202502016, 202410244, 202508284, 202409124, 202503245, 202502134, 202509224, 202502145, 202409136, 202412055, 202411085, 202508014, 202410094, 202507024, 202509194, 202508134, 202507174, 202501154, 202501304, 202501295, 202506114, 202504214, 202506054, 202505176, 202412165, 202409024, 202501025, 202412235, 202408235, 202410165, 202501145, 202406254. Manufactured from 14 June 2024 to 12 January 2026.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98854).

Sources and updates

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