High Flow Irrigation Extender — Class II medical device recall Z-0818-2016
Terminated recall by Smith & Nephew, Inc., Endoscopy Div., reported 2016-02-24, distributed in AK, AL, AR, CA, FL, GA, ID, IL…. During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender s
| Recall number | Z-0818-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2016-02-17 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2021-02-24 |
| Distributed | AK, AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX |
| Countries outside the US | JP |
| Quantity | 203 units |
| Reason classes | packaging |
| Model numbers | 72201021 |
Product
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Reason for recall
During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
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-0818-2016. 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.