Z-0786-2020Class II

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

Name: Z-0786-2020 Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway...
Creator: Intersurgical Inc
Published: 2019-08-07
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2019-08-07 / Terminated

FDA source

Intersurgical Inc began a recall of Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector on 2019-08-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0786-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-07
Posted: 2020-01-08
Terminated: 2020-12-15
Recalling firm: Intersurgical Ltd.
Product: Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
Product code: BZA Connector, Airway (Extension)
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.
FDA root cause: Under Investigation by firm
Action: Intersurgical Inc. issued Urgent Medical Device Recall notices to customers dated August 5, 2019. Customers were advised to take the following actions: 1. Immediately discontinue use and quarantine any stock with the product/lot number described in the recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. a. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form: i. Return the completed form via email to Intersurgical Inc. at [email protected]. ii. The subject line should contain your Company name and RGA number. 1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. b. Intersurgical will credit your account when the product is received. 4. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. a. Return the completed form via email to Intersurgical Inc. at [email protected]. b. The subject line should contain your Company name and Intersurgical Recall
Quantity in commerce: 19,200 pieces
Distribution: US Nationwide
Product codes and lots: Lot numbers: 2180531, 2181808, 2182241, 2182533

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0786-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0784-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-08
Z-0785-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-08
Z-0786-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-08
Z-0787-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-08

Product code BZA

K911421Class ICatheter MountsIntersurgical, Inc. / cleared 1991-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)