Severity
Moderate
FDA Devices recall · Reported January 15, 2020
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.
Intersurgical Inc recalled Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 350… - a moderate-severity action.
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 350… was recalled by Intersurgical Inc in January 15, 2020. Reason: The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak i…. Check the official notice for the remedy. Verify recall #Z-0786-2020 with the FDA Devices before acting.
The recall
Intersurgical Inc issued this moderate-severity FDA Devices recall-The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak i….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0786-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0786-2020) was formally reported on January 15, 2020, with the manufacturer initiating the action on August 7, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Intersurgical Inc is listed as the recalling firm, operating out of East Syracuse, NY. Federal records list the affected scope as 19,200 pieces.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
19,200 pieces
Related Recalls
6
3 from same agency
Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0786-2020 |
| Date reported | January 15, 2020 |
| Date initiated | August 7, 2019 |
| Recalling firm | Intersurgical Inc |
| Firm location | East Syracuse, NY |
| Affected scope | 19,200 pieces |
| Distribution | US Nationwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 15, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.