Food, drugs, devices › Intersurgical Inc
Device recall: Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002
Intersurgical Inc (E. Syracuse, NY) initiated this device recall on 3 Apr 2017; FDA lists 1 product record under event 76945, 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 17 Jun 2019. 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, E. Syracuse, NY.
Reason for recall
"A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated."
Distribution
"Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0208-2018 | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management. | 144 cases / 20 units | Class II | Terminated | 13 Dec 2017 |
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 |
| 20 Jun 2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | 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 |
All 8 events for Intersurgical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated."
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: "Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Jun 2019. "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.