FDA Device recall Z-2156-2014
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech
- FDA Device
- Class II
- terminated
- Published 2014-08-13
On 2014-08-13 the FDA classified a Class II recall of Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech by Stryker Instruments Div, citing the firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2156-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-24 |
| Published | 2014-08-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Reason
The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
Identifiers
| code_info | Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 10182…Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255 06C0503 07G0752 08L1004 1018200094 1106700024 1202400234 1231200324 1320000094 01H0006 04G0256 06C0504 07G0753 08L1005 1018200104 1106800014 1202400244 1232000014 1320000104 01H0007 04G0257 06C0505 07G0754 08L1006 1018900014 1106800024 1203200214 1232000024 1320600014 01H0008 04G0258 06C0506 07G0755 09A1007 1018900024 1106800034 1203200224 1232000034 1320600024 01H0009 04G0263 06C0507 07G0756 09A1008 1018900034 1106800044 1203200234 1232000044 1320600034 01H0010 04G0264 06C0508 07G0757 09A1009 1018900044 1106800054 |
|---|
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-2156-2014%22
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