ConMed AirSeal Access Port Recall Issued for Overpressure Alerts
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 55,694 packs of its AirSeal 8mm Access Port due to potential overpressure alerts. The Class II recall affects devices distributed nationwide and internationally.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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, Devices.
What Happened
ConMed Corporation initiated a voluntary recall due to the potential for overpressure alerts with the affected devices.
Which Products Are Affected
The recall covers ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length (Catalog Number: iAS8-120LP). The product is sold in packs of 6 units and identified by UDI-DI 10845854045657. A total of 55,694 packs (344,166 eaches) are affected, with numerous lot numbers manufactured from June 14, 2024, to January 12, 2026. Distribution was nationwide in the United States and to multiple international countries.
What You Should Do
Consumers and healthcare facilities should follow instructions provided in the firm's notifications regarding the recalled devices.
Why This Matters
The Class II recall involves devices that may experience overpressure alerts, which could affect use during laparoscopic procedures.
Source
FDA Recall Z-2467-2026 - 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 (1,023 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.