Stryker Recalls RF MultiGen Generator Instructions Due to Sterilization Errors
Stryker is voluntarily recalling Care Instructions for the RF MultiGen Generator because they incorrectly support sterilizing the cables.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving a documentation error (incorrect instructions) rather than a physical defect or contamination, which is unlikely to cause adverse health consequences.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the Care Instructions and Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator. The recall is being conducted because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen cables.
The affected products are the RF MultiGen, 0406-900-000, and Refurb RF MultiGen, 0406-900-000U. A total of 2,675 units were distributed domestically to numerous states and territories, as well as to foreign countries including France, Germany, Canada, and the UK. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 2,675
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)
- RF MultiGen¿
- 0406-900-000
- Refurb RF MultiGen¿
- 0406-900-000U
Distribution
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