Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect
Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of harm (excessive heat) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 2,460 units of the Sonopet Ultrasonic Surgical System Console and Ultrasonic Aspirator. The recall covers units distributed nationwide, including the District of Columbia and all 50 states.
The recall was initiated after the firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. The source text states that lack of irrigation can potentially lead to excessive heat at the tip.
Affected units are identified by specific part numbers (5450-850-000, 5450-851-000, 5450-852-000, UST-2001) and a long list of serial numbers provided in the official recall notice. Healthcare facilities and users should check their inventory against the provided serial numbers and contact Stryker for instructions on how to proceed.
The recalled product
- Product
- Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 2,460
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 (4)
- Part #'s: 5450-850-000
- 5450-851-000
- 5450-852-000
- UST-2001
Distribution
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