ConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
ConMed AirSeal 12 mm Access Ports with Low Profile Bladeless Optical Tip Obturators are being recalled because of the potential for overpressure alerts. 71,151 packs affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a malfunction arising during laparoscopic use, a risk of harm with no injuries reported in the source.
Plain-English summary
The ConMed AirSeal 12 mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120 mm length, catalog number iAS12-120LPI, six units per pack, is being recalled. The product is a disposable endoscopic trocar and cannula used with a carbon dioxide insufflator for laparoscopy. The action covers 71,151 packs, totalling 426,908 units.
The stated reason is the potential for overpressure alerts. The FDA classified the action as Class II.
Affected product is UDI-DI 10845854045688, spanning the lot numbers listed in the recall notice including 202506164 and 202507144. Distribution was nationwide in the United States and internationally to Australia, Austria, Belgium and other markets.
Facilities should identify affected stock using the catalog number, UDI-DI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by ConMed.
The recalled product
- Product
- ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
- Manufacturer
- ConMed Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number: iAS12-120LPI. UDI-DI: 10845854045688. Lot Numbers: 202506164
- 202507144
- 202506274
- 202506136
- 202506124
- 2025071010
- 202507114
- 202506244
- 202505194
- 202505164
- 202505064
- 202505144
- 202509114
- 202508204
- 202509124
- 202510184
- 202509274
- 202511064
- 202509254
- 202509264
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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