FDA Device recall Z-0787-2020
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000
- FDA Device
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000 by Intersurgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0787-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-07 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intersurgical |
| Distribution | US |
Product
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Reason
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.
Identifiers
| code_info | Lot numbers: 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0787-2020%22
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