Z-0289-2017Class II

Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible...

Name: Z-0289-2017 Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible...
Creator: US Endoscopy Group Inc
Published: 2016-05-18
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2016-05-18 / Terminated

FDA source

US Endoscopy Group Inc began a recall of Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the... on 2016-05-18. FDA classified it as Class II and gives the reason as "US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0289-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Posted: 2016-10-19
Terminated: 2017-05-10
Recalling firm: United States Endoscopy Group, Inc.
Product: Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Product code: FBK Endoscopic Injection Needle, Gastroenterology-Urology
Reason for recall: US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
FDA root cause: Other
Action: US Endoscopy sent an Urgent- (Vari Safe) injection needle recall letter dated July 6, 2016. US Endoscopy requests that you: 1.Quarantine the affected Vari-Safe Injection devices in your stock. 2. Destroy each affected device by opening the device package, cutting the device catheter with a scissors, and then discarding the device and package. 3.Complete the attached Customer Response Card and return to the attention of US Endoscopy Customer Service, via fax 1-440-639-4495 or email orders@us endos copy.com . A no charge replacement will be provided for each unused Vari-Safe Injection Needle device from the affected lot. We apologize for any inconvenience this matter may cause you, and as always, US Endoscopy is dedicated to supporting our products and valued Customers. For further questions please call (800) 769-8226.
Quantity in commerce: 36 units
Distribution: US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Product codes and lots: Model #: 00711819; Lot 1520268

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0289-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-19

Product code FBK

K971842Class IICoaxial NeedleUnited States Endoscopy Group, Inc. / cleared 1997-06-20

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)