Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance
Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.
What this means for you
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: This is an FDA Class II recall for a medical device distributed without required clearance. No injuries or illnesses have been reported, and the hazard is regulatory non-compliance rather than an inherent product defect. The recall is precautionary in nature.
Plain-English summary
Jewel Precision Sheet Metal & Machining Co, Inc. is recalling the Jewel Precision Reusable Rigid Sterilization Container System, Model Number JP-24-8 (GTIN: 00850043393139, Lot Number: 16899), distributed to Tennessee. The 8-inch model was not cleared by the FDA prior to distribution.
The FDA determined that the letter to file submitted to justify the change in size was insufficient. As a result, the product does not have the required regulatory clearance for distribution and use.
Consumers and healthcare facilities in possession of this product should discontinue use and contact Jewel Precision Sheet Metal & Machining Co, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
- Manufacturer
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Hazard
- regulatory-non-compliance
- uncleared-device
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 (1)
- Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899
Distribution
Distribution scope not specified by the agency.
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