Aesculap Recalls JS Series SterilContainer S2 System for Premarket Clearance Issues
Aesculap Implant Systems LLC is recalling 292 units of the JS Series SterilContainer S2 System because they were released to the market before receiving authorized FDA 510K clearance.
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, but the source text does not report any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity score involving regulatory or procedural issues without reported harm.
Plain-English summary
Aesculap Implant Systems LLC is recalling 292 units of the JS Series SterilContainer S2 System. The recall is being conducted because the product was released to the marketplace prior to receiving an authorized FDA 510K clearance. The affected products were distributed nationally.
The recall covers specific container bottoms and lids for the JS Series SterilContainer S2 System, including various sizes such as 1/1, 3/4, and 1/2 configurations. The source text explicitly states that no other Aesculap SterilContainer System products are impacted by this recall.
Consumers and healthcare facilities should stop using the affected units and contact the recalling firm for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of the product might cause temporary or medically reversible health consequences.
The recalled product
- Product
- JS Series SterilContainer S2 System
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 292
Distribution
Distribution scope not specified by the agency.
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