ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-
Summary
The FDA issued a Class II for ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical by ConMed Corporation. Reason: Potential for overpressure alerts..
Details
Source
Device Recall
External ID
Z-2471-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Lot/Code Info: Catalog Number: iAS5-100LP. UDI-DI: 10845854045626. Lot Numbers: 202509104, 202502195, 202502255, 202503115, 202503205, 202504084, 202503114, 202503035, 202503204, 202510214, 202511044, 202511055, 202510144, 202510284, 202510134, 202511184, 202510294, 202510224, 202511066, 202511124, 202511144, 202511154, 202505284, 202506064, 202506204, 202507014, 202504074, 202507154, 202507294, 202507164, 202507284, 202506194, 202507024, 202505194, 202504014, 202503215, 202505274, 202511134, 202509154, 202509294, 202508274, 202509234, 202510014, 202508044, 202508134, 202508154, 202509114, 202411224, 202509224, 202506216, 202410074, 202410155, 202410154, 202410224, 202412045, 202501064, 202509024, 202503116, 202504024, 202503124, 202502274, 202502175, 202411205, 202407094, 202503206, 202502264, 202408224, 202409105, 202411264, 202506074, 202412164, 202509304, 202601124, 202502184, 202512024, 202502194, 202506094, 202509014, 202508264, 202509124, 202506184, 202506234, 202507074, 202508014, 202508184, 202411255, 202411204, 202510074, 202408305, 202406215, 202501296, 202410025, 202406205, 202411214, 202410284, 202409245, 202410164, 202409186, 202407194, 202410084, 202412134, 202409246, 202502114, 202502054, 202502045, 202411254, 202409244, 202502116, 202407254, 202406285, 202502105, 202412035, 202406214, 202408135, 202502265, 202511114, 202409235, 202509244, 202408064, 202503214, 202503046, 202507214, 202512014, 202409286, 202502276, 202501035, 202501036, 202504164, 202503055, 202507034, 202408134, 202407095, 202412065. *OUS added 06/10/2026 expansion: 202409244, 202511044, 202511066, 202511055, 202508274, 202509104, 202506194, 202508134, 202508154, 202507294, 202505194, 202507014, 202507024, 202503114, 202503215, 202504014, 202412164, 202412135, 202501036, 202501294, 202501064, 202412065, 202411225, 202408064, 202412145, 202501065, 202510014, 202407014, 202505274, 202410155, 202406205, 202508044, 202510294, 202511144, 202410094, 202407254, 202510144, 202509294, 202509154, 202507154, 202506204, 202502195, 202501035, 202502045, 202411254, 202409104, 202409245, 202406214, 202504074, 202407194, 202408224, 202406215, 202503115, 202510134, 202506064, 202503204, 202503035, 202509234, 202502114, 202507284, 202505284, 202501295, 202407094, 202502255, 202408134, 202510284, 202511134, 202507164, 202504084, 202412044, 202510074, 202511124, 202508184, 202412134, 202510224, 202510214, 202509304, 202506234, 202509024, 202507034, 202507074, 202507044, 202510064, 202509124, 202510034, 202508264, 202506094, 202506184, 202502105, 202502274, 202503065, 202503205, 202503226, 202509224, 202503055, 202411214, 202512024, 202410154, 202506216, 202503116, 202503124, 202601124, 202412045, 202411224, 202410224, 202509014, 202409105, 202410074, 202509114, 202503206, 202502184, 202509244, 202502276, 202411264, 202502116, 202408215, 202411195, 202408305, 202408144, 202411204, 202410025, 202408135, 202409246, 202410084, 202406285, 202502264, 202503046, 202507214, 202502054, 202502175, 202410284, 202410164, 202502265, 202507174, 202504024, 202411255, 202508014, 202410035, 202502194, 202410255, 202409024, 202410045, 202408264, 202410235, 202406244, 202409286, 202408304, 202407095, 202408065, 202406284, 202511114, 202502185, 202502186, 202412054, 202411215, 202408075, 202409175, 202502196, 202503214, 202504164, 202411205, 202409174, 202409235, 202406204. Manufactured from 14 June 2024 to 12 January 2026.
Quantity Affected: 36,462 packs (219,850 eaches)
Reason for Recall
Potential for overpressure alerts.
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. .
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-14
Company
Utica, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ConMed Corporation has 29 FDA actions in our database, including 12 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConMed Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConMed Corporation have FDA actions?
ConMed Corporation has 29 FDA actions in our database, including 12 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2471-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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