CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report
Superset with ID, Double Swivel Elbow OD/ ID and Bronchoscopy Port recalled
Intersurgical is recalling Superset with ID, Double Swivel Elbow OD/ ID and Bronchoscopy Port, distributed nationwide in the US. The recall was initiated on 7 Aug 2019 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-0787-2020
- FDA event ID
- 83527
- Recalling firm
- Intersurgical, East Syracuse, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2019
- FDA classified
- 8 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2019 | Recall initiated by company | |
| 8 Jan 2020 | Classified by FDA | +154 days |
| 15 Jan 2020 | 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
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
Which lots are affected?
Lot numbers: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591
Where was it sold?
US Nationwide
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
3 other products · FDA event 83527This product is part of a recall event; the main page for the event is Superset with ID, Double Swivel Elbow OD/ ID and Bronchoscopy Port recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Superset with ID, Double Swivel Elbow OD/ ID and Bronchoscopy Port recalled | Intersurgical | Packaging Defects | Nationwide | |
| CLASS II | Double Swivel Elbow with Bronchoscopy Port OD/ ID recalled | Intersurgical | Packaging Defects | Nationwide | |
| CLASS II | Double Swivel Elbow with Bronchoscopy Port OD/ ID recalled | Intersurgical | Packaging Defects | Nationwide |
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 |
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