ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 5 mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100 mm length, catalog number iAS5-100LP, 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 36,462 packs, totalling 219,850 units.
The stated reason is the potential for overpressure alerts. The FDA classified the action as Class II.
Affected product is UDI-DI 10845854045626, spanning the lot numbers listed in the recall notice including 202509104 and 202502195. 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 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 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: iAS5-100LP. UDI-DI: 10845854045626. Lot Numbers: 202509104
- 202502195
- 202502255
- 202503115
- 202503205
- 202504084
- 202503114
- 202503035
- 202503204
- 202510214
- 202511044
- 202511055
- 202510144
- 202510284
- 202510134
- 202511184
- 202510294
- 202510224
- 202511066
- 202511124
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.
See all 11 products in this recall →Related recalls
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