ConMed AirSeal 12mm Access Port Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ConMed Corporation is recalling 1,261 packs of AirSeal 12mm Access Port and Obturator due to potential overpressure alerts.
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 and International. 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, Devices.
What Happened
ConMed Corporation initiated a voluntary recall of specific AirSeal devices after identifying a potential for overpressure alerts.
Which Products Are Affected
The recall involves ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length, Catalog Number iASB12-100. Affected lot numbers include 202510034, 202505134, 202507234, 202510094, 202503184, 202408306, 202407044, 202412194, 202512014, 202512024, 202410085, and 202411264. A total of 1,261 packs (7,566 eaches) were distributed nationwide in the United States and internationally to multiple countries including Australia, Canada, China, and others. The products were manufactured from June 14, 2024, to January 12, 2026. UDI-DI is 10851885004310. Recall number Z-2466-2026. Classification: Class II.
What You Should Do
Customers should follow instructions provided by ConMed Corporation via email, fax, letter, or other notifications regarding the recalled devices.
Why This Matters
This Class II recall addresses a device malfunction that could lead to temporary or reversible adverse health consequences.
Source
FDA Enforcement Report, recall number Z-2466-2026
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 (1,171 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.