[pending] ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-1
Pending LLM rewrite. Source: FDA_DEVICE Z-2466-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential for overpressure alerts.
The recalled product
- Product
- ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
- Manufacturer
- ConMed Corporation
- Category
- Medical Device — Devices
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 (14)
- Catalog Number: iASB12-100. UDI-DI: 10851885004310. Lot Numbers: 202510034
- 202505134
- 202507234
- 202510094
- 202503184
- 202408306
- 202407044
- 202412194
- 202512014
- 202512024
- 202410085
- 202411264. *OUS added 06/10/2026 expansion: 202510034
- 202411264
- 202510094. Manufactured from 14 June 2024 to 12 January 2026.
Distribution
Distributed nationwide across the United States.
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