Vari-Safe Injection Needle US endoscopy 5976 Heisley Road… recallZ-0289-2017 · US Endoscopy Group Inc · initiated May 18, 2016
Class II Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from US Endoscopy Group Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0289-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 18, 2016
- Posted by the FDA
- Oct 19, 2016
- Recalling firm
- US Endoscopy Group Inc
- Quantity
- 36 units
- Product code
- FBK
- FDA submissions
- K971842
- Distribution
- US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Product description
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
Code information (models, lots, serial numbers)
Model #: 00711819; Lot 1520268
Other devices under the same FDA submission
5 devices cleared under K971842 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 00711811US Endoscopy · Biopsy needle11 reports
- NA 00711812US Endoscopy · Biopsy needle6 reports
- Articulator 00711807US Endoscopy · Biopsy needle4 reports
- Articulator 00711810US Endoscopy · Biopsy needle3 reports
- NA 00711822US Endoscopy · Biopsy needle1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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