Sonopet Ultrasonic Surgical System Console — Class II medical device recall Z-2156-2014
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2014-08-13, distributed nationwide. The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrig
| Recall number | Z-2156-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2014-06-24 |
| Classified | 2014-08-07 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,460 units |
| Serial numbers | 01H0001, 01H0002, 01H0003, 01H0004, 01H0005, 01H0006, 01H0007, 01H0008, 01H0009, 01H0010, 01I0011, 01I0012, 01I0013, 01I0014, 01I0015, 01J0016, 01J0017, 01J0018, 01J0019, 01J0020, 01J0021, 01J0022, 01J0023, 01J0024, 01J0025 and 475 more |
| Model numbers | 5450-850-000, 5450-851-000, 5450-852-000, UST-2001 |
Product
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Reason for recall
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.
Machine access
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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.