[pending] Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Pending LLM rewrite. Source: FDA_DEVICE Z-2033-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
The recalled product
- Product
- Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
- Manufacturer
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Category
- Medical Device — Devices
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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