Food, drugs, devices › Intersurgical Inc
Device recall: One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
FDA enforcement event 97127 is a device recall by Intersurgical Inc of East Syracuse, NY, initiated 20 Jun 2025 and classified Class II, with 2 product records.
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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Intersurgical Inc has 8 enforcement events on this register, with a median of 1 product record 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
Intersurgical Inc, East Syracuse, NY.
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."
Distribution
"US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2275-2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | 2,800 pieces | Class II | Ongoing | 13 Aug 2025 |
| Z-2276-2025 | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | 8,640 pieces | Class II | Ongoing | 13 Aug 2025 |
Context
Other enforcement events for Intersurgical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Jun 2026 | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. | Device | Class II | 2 |
| 17 Jun 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy. | Device | Class I | 1 |
| 29 Aug 2022 | Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 | Device | Class II | 1 |
| 11 Nov 2020 | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multi | Device | Class II | 1 |
| 7 Aug 2019 | Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector. | Device | Class II | 4 |
| 25 Apr 2018 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 | Device | Class II | 1 |
| 3 Apr 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002 | Device | Class II | 1 |
All 8 events for Intersurgical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
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 distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA."
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.