FDA Device recall Z-2080-2014
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip by Stryker Endoscopy, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2080-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-20 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
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
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.
Identifiers
| code_info | P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2080-2014%22
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