Data Foundry

Medical device recalls 2020

Superset with 22MM ID — Class II medical device recall Z-0786-2020

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 numberZ-0786-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntersurgical Inc, East Syracuse, NY, United States
Recall initiated2019-08-07
Classified2020-01-08
Reported by FDA2020-01-15
Terminated2020-12-15
DistributedNationwide (US)
Quantity19,200 units
Reason classespackaging
Lot numbers2180531, 2181808, 2182241, 2182533
Model numbers3503031

Product

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. 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-0786-2020. 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.