ConMed AirSeal Access Port Recall Issued
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ConMed Corporation recalls AirSeal 8mm Access Port devices due to potential overpressure alerts affecting 26,609 packs distributed nationwide and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
ConMed Corporation initiated a voluntary recall of specific AirSeal devices due to the potential for overpressure alerts.
Which Products Are Affected
The recall involves ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length (Catalog Number: iAS8-100LP). UDI-DI: 10845854045718. Affected lot numbers include 202509034, 202511194, 202509174, 202506264, 202506254, 202506274, 202507074, 202505096, 202507244, 202508124, 202508194, 202507084, 202504294, 202505074, 202504304, 202504155, 202505064, 202505094, 202505204, 202509244, 202511184, 2025102210, 202508254, 2025111110, 202510154, 202508054, 202508114, 202507254, 202509084, 202509054, 202411015, 202408155, 202503016, 202504234, 202505264, 202501134, 202411124, 202501135, 202412195, 202411305, 202511274, 202509274, 202511284, 202504284, 202504224, 202503194, 202504085, 202508184, 202510304, 202409034, 202409095, 202409094, 202408085, 202410104, 202506304, 202506054, 202510094, 202409025, 202410175, 202508264, 202408095, 202408125, 202411115, 202411014, 202506044, 202509194, 202511264, 202408274, 202412205, 202412025, 202501236, 202501235, 202501244, 202503156, 202503145, 202503144, 202504084, 202408094, 202408084, 202410105, 202502066, 202501094, 202509184, 202408275, 202408194, 202507144, 202507154, 202412024, 202501234, 202411295, 202504094, 202503196, 202503125, 202503126, 202503034, 202504145, 202408165, 2025081811, 202408154, 202503264, 202502055, 202411294, 202412106, 202601074, 2026010711, 202501225, 202412204, 202501245, 202409106, 202410315 along with additional OUS lots. A total of 26,609 packs (159,657 eaches) are affected. Manufactured from June 14, 2024 to January 12, 2026. Distributed nationwide in the United States and 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, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
What You Should Do
No specific consumer action steps are detailed in the recall notice.
Why This Matters
This Class II recall involves devices used in laparoscopic procedures with potential for overpressure alerts during use.
Source
FDA Recall Z-2468-2026 - ConMed Corporation, Utica, NY
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,698 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.