Superset with 22MM ID — Class II medical device recall Z-0787-2020
Terminated recall by Intersurgical Inc, reported 2020-01-15, distributed nationwide. The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if
| Recall number | Z-0787-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, East Syracuse, NY, United States |
| Recall initiated | 2019-08-07 |
| Classified | 2020-01-08 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2020-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 50,400 units |
| Reason classes | packaging |
| Lot numbers | 2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591 |
| Model numbers | 3521000 |
Product
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0787-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.