Food, drugs, devices › SunMed Holdings, LLC
Device recall: Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0
SunMed Holdings, LLC (Grand Rapids, MI) initiated this device recall on 22 Dec 2022; FDA lists 2 product records under event 91391, classified Class II.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. SunMed Holdings, LLC has 6 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SunMed Holdings, LLC, Grand Rapids, MI.
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."
Distribution
"US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1019-2023 | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405 | 43,290 (Eaches) | Class II | Ongoing | 1 Feb 2023 |
| Z-1020-2023 | 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 | 43,290 (Eaches) | Class II | Ongoing | 1 Feb 2023 |
Context
Other enforcement events for SunMed Holdings, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Dec 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Vers | Device | Class I | 4 |
| 15 May 2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-234 | Device | Class I | 1 |
| 1 May 2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F | Device | Class I | 1 |
| 11 Oct 2023 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include | Device | Class II | 9 |
| 8 Sep 2022 | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | Device | Class II | 1 |
All 6 events for SunMed Holdings, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 use a smaller-diameter gastric catheter."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.