Z-0075-2017Class II

Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use...

Name: Z-0075-2017 Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use...
Creator: Banyan Medical, LLC
Published: 2016-09-07
License: https://open.fda.gov/license/

Banyan Medical, LLC / initiated 2016-09-07 / Terminated / root cause: manufacturing process

FDA source

Banyan Medical, LLC began a recall of Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009 on 2016-09-07. FDA classified it as Class II and gives the reason as "Potential lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0075-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2016-10-13
Terminated: 2021-03-09
Recalling firm: Banyan Medical, LLC
Product: Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Potential lack of assurance of sterility
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Banyan Medical issued Urgent Voluntary Recall Notification on 9/7/16 to Distributors to remove product from inventory and contact hospital to examine and return product. Questions contact your local Banyan Sales Representative
Quantity in commerce: 64 boxes of 5
Distribution: IN, TN
Product codes and lots: Lot Numbers:140718, 160209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13
Z-0075-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code GCJ

K133375Class IIBanyan Medical Disposable Secondary Cannula and TrocarBanyan Medical, LLC / cleared 2014-01-17

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)