CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report
Solus Flexible wire-reinforced laryngeal mask airways under recalled
Intersurgical is recalling Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: small, distributed in Illinois, Kentucky, New York, Ohio, Virginia. The recall was initiated on 3 Apr 2017 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-0208-2018
- FDA event ID
- 76945
- Recalling firm
- Intersurgical, E. Syracuse, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2017
- FDA classified
- 7 Dec 2017
- Reported
- 13 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 3 Apr 2017 | Recall initiated by company | |
| 7 Dec 2017 | Classified by FDA | +248 days |
| 13 Dec 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
Questions about this recall
Why was it recalled?
A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.
Which lots are affected?
Product Lots: 31402822 to 31610791
Where was it sold?
Worldwide Distribution - US Distribution to the states of : IL, KY, OH, NY & VA and to the countries of : Canada & Mexico
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.
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 II | One-piece Guedel airway, size 2, ISO 8.0, green recalled | Intersurgical | Other | 10 states |
| Device | CLASS I | i-view video laryngoscope recalled by Intersurgical | Intersurgical | Other | 17 states |
Other Masks, Gloves & PPE recalls
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| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |