The Recall Desk
HighFDA (Devices)·Z-1880-2013·Announced 2013-08-14

Stryker Recalls Sonopet Ultrasonic Aspirator Consoles Due to 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 functional failure (irrigation pump stopping) poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 215 units of the Sonopet Ultrasonic Aspirator Console, model 5450-852-000 (Console 230V). 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 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. This defect could cause the irrigation pump to stop working. The irrigation pump is designed to supply saline during surgical procedures.

The affected consoles were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Canada, the United Kingdom, and Japan. The source text does not specify the actions consumers or healthcare facilities should take, nor does it report any injuries or illnesses associated with this recall.

The recalled product

Product
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) 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)

  • 5450-852-000 (Console 230V) with SN: 1134000114
  • 1206800484 1210900274
  • 1134000124
  • 1206800494
  • 1210900284
  • 1134000134 1206800504
  • 1210900294
  • 1134000144
  • 1206800514
  • 1210900304
  • 1134000154
  • 1206800524
  • 1211800064
  • 1134000164
  • 1206800534
  • 1211800074
  • 1134000174
  • 1206800544
  • 1211800084
  • 1134000184

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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