Z-1020-2023Class II

AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0...

Name: Z-1020-2023 AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0...
Creator: SunMed Holdings, LLC
Published: 2022-12-22
License: https://open.fda.gov/license/

Salter Labs / initiated 2022-12-22 / Open, Classified / root cause: labeling and UDI

FDA source

SunMed Holdings, LLC began a recall of 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 on 2022-12-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1020-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-01-26
Recalling firm: Salter Labs
Product: 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
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 22, 2022, the firm notified affected customers through Urgent Medical Device Product Correction letters. Customers were informed that there is a discrepancy in the orogastric (OG) tube size indicated in the labeling in the instructions for use (IFU) versus the printed text on the device. Customers were provided with the correct recommended maximum OG tube/catheter sizes for each impacted Air-Q3G and Air-Q SPG model. If product has been further distributed, customers should forward the recall notice. If customers have questions about this recall notification, please contact Rob Yamashita, VP of Regulatory Affairs, at 616-259-8400, toll free at 800-433-2729, or [email protected].
Quantity in commerce: 43,290 (Eaches)
Distribution: US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26
Z-1020-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)