The Recall Desk
HighFDA (Devices)·Z-1878-2013·Announced 2013-08-14

Stryker Sonopet Ultrasonic Aspirator Console Recall for Corrosion Defect

Stryker is recalling 215 Sonopet Ultrasonic Aspirator Consoles because corrosion on a power supply component may cause the irrigation pump to stop working during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a functional defect could cause the irrigation pump to stop working during surgery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 215 units of the Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole). The recall is limited to 215 units distributed worldwide, including the United States, Italy, Australia, Canada, the United Kingdom, the Netherlands, India, Japan, New Zealand, Switzerland, Hong Kong, and Taiwan.

The recall is due to a supplied component exhibiting corrosion that was built into the power supply boards of the affected consoles. The issue is limited to 2 lots of the supplied component. The presence of corrosion on the relay of the power supply board can potentially lead to a conduction defect, which could cause the irrigation pump to stop working. The irrigation pump is intended to supply saline during surgical procedures.

The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery. Affected units are identified by the product code 5450-850-000 and specific serial numbers listed in the agency record.

The recalled product

Product
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointest
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Equipment
Hazard
Affected units
215

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 5450-850-000 (Console 110V with Pedal & Pole) S/N 1131300134
  • 1131900074
  • 1200500134
  • 1203200244
  • 1210100114
  • 1131300144
  • 1131900084
  • 1200500144
  • 1203200254
  • 1210100124
  • 1131300154
  • 1131900094
  • 1200500154
  • 1203200274
  • 1210100134
  • 1131300164
  • 1131900104
  • 1200500164
  • 1203700954
  • 1210100144

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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