CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
One-piece Guedel airway, size 2, ISO 8.0, green recalled
Intersurgical is recalling One-piece Guedel airway, size 2, ISO 8.0, green, distributed in 10 states. The recall was initiated on 20 Jun 2025 and the FDA has classified it as Class II.
Check your package
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-2275-2025
- FDA event ID
- 97127
- Recalling firm
- Intersurgical, East Syracuse, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jun 2025
- FDA classified
- 6 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Jun 2025 | Recall initiated by company | |
| 6 Aug 2025 | Classified by FDA | +47 days |
| 13 Aug 2025 | 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 contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Product as listed by the FDA
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Where it was distributed
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
ArizonaCaliforniaConnecticutFloridaHawaiiMassachusettsMichiganOhioUtahVirginia
Questions about this recall
Why was it recalled?
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Which lots are affected?
Model Number: 1112080. UDI-DI (Case): 05030267040698, UDI-DI (Single Unit): 5030267050659. Lot Number: 32414447
Where was it sold?
US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
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 97127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | One-piece Guedel airway, size 3, ISO 9.0, yellow recalled | Intersurgical | Other | 10 states |
More recalls from Intersurgical
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | One-Piece Guedel Airway, size 00, ISO 5.0, Blue recalled | Intersurgical | Other | Nationwide |
| Device | CLASS II | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green recalled | Intersurgical | Other | Nationwide |
| Device | CLASS II | One-piece Guedel airway, size 3, ISO 9.0, yellow recalled | Intersurgical | Other | 10 states |
| Device | CLASS I | i-view video laryngoscope recalled by Intersurgical | Intersurgical | Other | 17 states |
| Device | CLASS II | Solus Standard, laryngeal mask airway, size 3, small adult recalled | Intersurgical | Other | OH, TN, TX |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |