The Recall Desk
HighFDA (Devices)·Z-1879-2013·Announced 2013-08-14

Stryker Sonopet Ultrasonic Aspirator Console Recalled for Corrosion

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

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 medical device where a defect could cause the irrigation pump to stop working during surgery. This is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 215 units of the Sonopet Ultrasonic Aspirator Console (Model 5450-851-000, Console 100V). The recall is limited to specific serial numbers listed in the agency's structured data. The affected consoles were distributed worldwide, including in 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 consoles. This issue is limited to two 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. Users should check their serial numbers against the list provided by the manufacturer or the FDA to determine if their unit is affected.

The recalled product

Product
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) 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, gastrointestinal
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)

  • 5450-851-000(Console 100V) S/N 1127900134
  • 1133400114
  • 1202400224
  • 1205800094
  • 1226800284
  • 1127900144
  • 1133400124
  • 1202400234
  • 1205800104
  • 1226800294
  • 1127900154
  • 1133400134
  • 1202400244
  • 1206200574
  • 1226800304
  • 1127900164
  • 1133400144
  • 1203700594
  • 1206200584
  • 1228500194

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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