Disposable StrykeFlow Tip — Class II medical device recall Z-2080-2014
Terminated recall by Stryker Endoscopy, reported 2014-07-30, distributed nationwide. Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed bli
| Recall number | Z-2080-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2014-06-20 |
| Classified | 2014-07-18 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, GB, GR, KR, NL |
| Reason classes | sterility |
| Lot numbers | 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2, 14021FG2 |
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Reason for recall
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
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-2080-2014. 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.