Jewel Precision Reusable Rigid Sterilization Container System 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.
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 classified this as Class II and no reported illnesses or injuries are mentioned in the source. The hazard is a labeling/instruction discrepancy with the potential for user confusion, which constitutes a moderate-severity documentation issue.
Plain-English summary
Jewel Precision Sheet Metal & Machining Co, Inc. is recalling the Jewel Precision Reusable Rigid Sterilization Container System, Model No. JP-24-6 (GTIN: 00850043393016). The Instructions for Use do not match the FDA-cleared indications for use or sterility shelf life.
This device is a reusable rigid sterilization container system. The recall affects 11 units distributed nationwide to customers in Indiana, New York, and Pennsylvania. All units shipped up to May 23, 2025 are included in this recall.
Users of this product should review their Instructions for Use against the FDA-cleared indications and sterility shelf life to ensure proper use and sterilization. Contact Jewel Precision Sheet Metal & Machining Co, Inc. for corrected Instructions for Use or further information.
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
- instruction-mislabeling
- documentation-error
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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