CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

AirSeal Access Port and Low Profile Obturator recalled by ConMed

ConMed is recalling ConMed AirSeal Access Port and Low Profile Obturator with Bladeless Optical Tip Length, distributed nationwide in the US. The recall was initiated on 14 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: iAS5-120LP. UDI-DI: 10845854045657. Lot Numbers: 202504214, 202511075, 202510254, 202510274, 202510244, 202511104, 202601084, 202506054, 202506114, 202506104, 202505164, 202505294, 202505154, 202505176, 202507174, 202507184, 202507214, 202507044, 202506244, 202507024, 202507034, 202510024, 202510104, 202509194, 202507314, 202508134, 202508144, 202509224, 202509164, 202508294, 202509084, 202507315, 202507294, 202410094, 202410254, 202411114, 202409254, 202409255, 202505014, 202504224, 202502174, 202502254, 202504034, 202408234, 202501145, 202412124, 202408305, 202511064, 202510234, 202409114, 202409126, 202410174, 202510084, 202407105, 202502115, 202411194, 202508154, 202502134, 202502145, 202501174, 202510074, 202509094, 202505054, 202508014, 202506094, 202506174, 202506164, 202511065, 202601094, 202406245, 202409146, 202501316, 202502044, 202501154, 202502016, 202501155, 202501024, 202502245, 202503245, 202503266, 202503244, 202504044, 202504046, 202504164, 202407195, 202408235, 202407104, 202407224, 202410244, 202411074, 202412054, 202508274, 202501304, 202501144, 202504025, 202502135, 202501315, 202501295, 202504304, 202408225, 202409115, 202502045, 202504305, 202509014, 202509154, 202410165, 202408054, 202412174, 202412055, 202502126, 202501035, 202409135, 202507304, 202508284, 202409124, 202501305, 202410075, 202409125, 202502244, 202412165, 202501025, 202502156, 202511076, 202411075, 202510014, 202408024, 202412064, 202409264, 202411195, 202504174, 202412175, 202411084, 202509204, 202510114, 202412234, 202409136, 202409134, 202408145, 202409256, 202411085, 202601074, 202501306, 202409024, 202510284, 202406244, 202408015, 202502256, 202506234, 202503074, 202408124, 202502056, 202407024, 202412184, 202410245, 202410255, 202410104, 202409275, 202408144, 202409116. *OUS added 06/10/2026 expansion: 202407015, 202506104, 202501024, 202510244, 202511104, 202510274, 202508144, 202510024, 202510104, 202507034, 202507184, 202505054, 202505164, 202506244, 202412064, 202412184, 202408025, 202510254, 202507314, 202507044, 202503244, 202409256, 202509154, 202507315, 202506174, 202510074, 202412175, 202501305, 202504034, 202505154, 202407224, 202407105, 202505014, 202501316, 202502245, 202511065, 202409254, 202411194, 202410254, 202409114, 202511075, 202507214, 202407104, 202601084, 202412054, 202509164, 202504305, 202505294, 202408225, 202407024, 202509084, 202504304, 202502115, 202408054, 202509014, 202410255, 202601094, 202409125, 202408015, 202406245, 202510014, 202410245, 202501315, 202502016, 202410244, 202508284, 202409124, 202503245, 202502134, 202509224, 202502145, 202409136, 202412055, 202411085, 202508014, 202410094, 202507024, 202509194, 202508134, 202507174, 202501154, 202501304, 202501295, 202506114, 202504214, 202506054, 202505176, 202412165, 202409024, 202501025, 202412235, 202408235, 202410165, 202501145, 202406254. Manufactured from 14 June 2024 to 12 January 2026.

Quantity recalled32,792 packs (196,751 eaches)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2470-2026
FDA event ID: 98854
Recalling firm: ConMed, Utica, NY
Classification: Class II
Status: Ongoing
Recall initiated: 14 May 2026
FDA classified: 17 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

14 May 2026	Recall initiated by company
17 Jun 2026	Classified by FDA	+34 days
24 Jun 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for overpressure alerts.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Where it was distributed

Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .

Nationwide

Questions about this recall

Is AirSeal Access Port and Low Profile Obturator with Bladeless Optical Tip Length recalled?

Yes. ConMed recalled AirSeal Access Port and Low Profile Obturator with Bladeless Optical Tip Length on 14 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2470-2026.

Why was it recalled?

Potential for overpressure alerts.

Which lots are affected?

Catalog Number: iAS5-120LP. UDI-DI: 10845854045657. Lot Numbers: 202504214, 202511075, 202510254, 202510274, 202510244, 202511104, 202601084, 202506054, 202506114, 202506104, 202505164, 202505294, 202505154, 202505176, 202507174, 202507184, 202507214, 202507044, 202506244, 202507024, 202507034, 202510024, 202510104, 202509194, 202507314, 202508134, 202508144, 202509224, 202509164, 202508294, 202509084, 202507315, 202507294, 202410094, 202410254, 202411114, 202409254, 202409255, 202505014, 202504224, 202502174, 202502254, 202504034, 202408234, 202501145, 202412124, 202408305, 202511064, 202510234, 202409114, 202409126, 202410174, 202510084, 202407105, 202502115, 202411194, 202508154, 202502134, 202502145, 202501174, 202510074, 202509094, 202505054, 202508014, 202506094, 202506174, 202506164, 202511065, 202601094, 202406245, 202409146, 202501316, 202502044, 202501154, 202502016, 202501155, 202501024, 202502245, 202503245, 202503266, 202503244, 202504044, 202504046, 202504164, 202407195, 202408235, 202407104, 202407224, 202410244, 202411074, 202412054, 202508274, 202501304, 202501144, 202504025, 202502135, 202501315, 202501295, 202504304, 202408225, 202409115, 202502045, 202504305, 202509014, 202509154, 202410165, 202408054, 202412174, 202412055, 202502126, 202501035, 202409135, 202507304, 202508284, 202409124, 202501305, 202410075, 202409125, 202502244, 202412165, 202501025, 202502156, 202511076, 202411075, 202510014, 202408024, 202412064, 202409264, 202411195, 202504174, 202412175, 202411084, 202509204, 202510114, 202412234, 202409136, 202409134, 202408145, 202409256, 202411085, 202601074, 202501306, 202409024, 202510284, 202406244, 202408015, 202502256, 202506234, 202503074, 202408124, 202502056, 202407024, 202412184, 202410245, 202410255, 202410104, 202409275, 202408144, 202409116. *OUS added 06/10/2026 expansion: 202407015, 202506104, 202501024, 202510244, 202511104, 202510274, 202508144, 202510024, 202510104, 202507034, 202507184, 202505054, 202505164, 202506244, 202412064, 202412184, 202408025, 202510254, 202507314, 202507044, 202503244, 202409256, 202509154, 202507315, 202506174, 202510074, 202412175, 202501305, 202504034, 202505154, 202407224, 202407105, 202505014, 202501316, 202502245, 202511065, 202409254, 202411194, 202410254, 202409114, 202511075, 202507214, 202407104, 202601084, 202412054, 202509164, 202504305, 202505294, 202408225, 202407024, 202509084, 202504304, 202502115, 202408054, 202509014, 202410255, 202601094, 202409125, 202408015, 202406245, 202510014, 202410245, 202501315, 202502016, 202410244, 202508284, 202409124, 202503245, 202502134, 202509224, 202502145, 202409136, 202412055, 202411085, 202508014, 202410094, 202507024, 202509194, 202508134, 202507174, 202501154, 202501304, 202501295, 202506114, 202504214, 202506054, 202505176, 202412165, 202409024, 202501025, 202412235, 202408235, 202410165, 202501145, 202406254. Manufactured from 14 June 2024 to 12 January 2026.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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24 Jun 2026Device	CLASS II	AirSeal Access Port and Obturator with Blunt Tip Length recalled	ConMed	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Low Profile Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Palm Grip Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide

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