Data Foundry

Medical device recalls 2014

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 numberZ-2156-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Instruments Div. of Stryker Corporation, Portage, MI, United States
Recall initiated2014-06-24
Classified2014-08-07
Reported by FDA2014-08-13
Terminated2015-10-27
DistributedNationwide (US)
Quantity2,460 units
Serial numbers01H0001, 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 numbers5450-850-000, 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

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-2156-2014. 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.