Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date
Smith & Nephew is recalling 2,646 Dyonics Saw Blades because they are provided sterile but lack an expiration date on the label.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (missing expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 2,646 units of the Dyonics Saw Blade, Standard, Product Number 3701. The recall is due to a labeling defect where the single-use devices are provided sterile but do not have an expiration date on the label.
The affected products were distributed nationwide and in foreign countries including Brazil, Canada, Chile, China, Denmark, Hong Kong, India, Mexico, Peru, Singapore, and Venezuela. The recall involves specific batch numbers, including 50586138, 50458123, and 50418120.
Healthcare providers and consumers should stop using the affected products and contact Smith & Nephew for further instructions.
The recalled product
- Product
- Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 2,646
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smith & Nephew, Inc. 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.
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