SunMed Holdings, LLC: Medical Device Recall in 2023 - (Recall #: Z-1020-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 22, 2022

Date Posted: February 1, 2023

Recall Number: Z-1020-2023

Event ID: 91391

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.

Status: Ongoing

Product Quantity: 43,290 (Eaches)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated