CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report

AirQ3 Self Pressurizing ILA recalled by SunMed Holdings

SunMed Holdings is recalling AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328

Quantity recalled43,290 (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-1020-2023
FDA event ID: 91391
Recalling firm: SunMed Holdings, Grand Rapids, MI
Classification: Class II
Status: Ongoing
Recall initiated: 22 Dec 2022
FDA classified: 26 Jan 2023
Reported: 1 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Dec 2022	Recall initiated by company
26 Jan 2023	Classified by FDA	+35 days
1 Feb 2023	Published in enforcement report	+6 days

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

Reason for recall

There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.

Product as listed by the FDA

AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405

Where it was distributed

US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.

Nationwide Alabama California Florida Michigan Ohio Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

ALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328

Where was it sold?

US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.

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

Other products in this recall event

1 other product · FDA event 91391

This product is part of a recall event; the main page for the event is Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size recalled.

Reported	Class	Recall	Company	Reason	Where
1 Feb 2023	CLASS II	Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size recalled	SunMed Holdings	Other	Nationwide

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