Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Superset with 22MM ID Recalled by Intersurgical Inc Due to The port may crack in the swivel elbow...

Date: August 7, 2019
Company: Intersurgical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Intersurgical Inc directly.

Affected Products

Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

Quantity: 50,400 pieces

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Intersurgical Inc

Intersurgical Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report