Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor — Class II medical device recall Z-0289-2017
Terminated recall by US Endoscopy Group Inc, reported 2016-10-26, distributed in OH, OR, WA. US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was i
| Recall number | Z-0289-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Endoscopy Group Inc, Mentor, OH, United States |
| Recall initiated | 2016-05-18 |
| Classified | 2016-10-19 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-05-10 |
| Distributed | OH, OR, WA |
| Countries outside the US | IT |
| Quantity | 36 units |
| Lot numbers | 1520268 |
| Model numbers | 00711819 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0289-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.