Jewel Precision Sterilization Container System Recalled for Instructions Mismatch
Jewel Precision Reusable Rigid Sterilization Container System (Model JP-24-6) is being recalled because the Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life. Healthcare facilities should reference FDA-cleared specifications.
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: FDA Class II device recall involving a documentation mismatch between the Instructions for Use and FDA-cleared specifications. No illnesses or injuries have been reported. This labeling discrepancy fits the 'minor labeling errors' category and warrants Moderate severity.
Plain-English summary
The Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-6, is being recalled. The product's Instructions for Use do not match the indications for use and sterility shelf life that were cleared by the FDA. This mismatch could result in improper use that affects the container's ability to maintain sterility.
Approximately 11 units were distributed to healthcare facilities nationwide in Indiana, New York, and Pennsylvania, with all affected lots shipped through May 23, 2025. Facilities that use this device should reference the FDA-cleared specifications for proper indications for use, procedures, and sterility shelf life instead of relying solely on the provided Instructions for Use.
The recalled product
- Product
- Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
- Manufacturer
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Hazard
- mis-labeling
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 (2)
- Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23
- 2025.
Distribution
Distributed nationwide across the United States.
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