FDA Device recall Z-1224-2013
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish
- FDA Device
- Class II
- terminated
- Published 2013-05-15
On 2013-05-15 the FDA classified a Class II recall of Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish by Stryker Endoscopy, citing the pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1224-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-27 |
| Published | 2013-05-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
Product
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Identifiers
| code_info | Manufacturer Part Number: 250-070-411 |
|---|
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-1224-2013%22
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