Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.

FDA device recall Z-2033-2025 · posted 2025-06-26 · Open, Classified

Recall details

Recalling firm

Jewel Precision Sheet Metal & Machining Co, Inc.

Reason for recall

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.

Action taken

Jewel Precision sent a "MEDICAL DEVICE RECALL" letter dated 5/23/2025 to the single consignee on 05/23/2025 via email. The consignee was instructed to; review all stock and inventory, return the product to Jewel Precision for destruction, complete the Acknowledgement and Receipt form on pages 3-4 of the letter indicating the actions taken and approval of completion, in the event that the product has been scrapped, please provide evidence of scrapping it and certification that the product has been destroyed by the customer. As per the customer's purchase order, the piece was to be used for testing purposes only. For products that have been shipped to your customers, identify and notify your customers of the recall, requesting return; obtain their acknowledgement and approval that the part has been shipped back. Action by company: discontinued the product. For questions email: jsitler@jewelprecision.com or call 973-857-5545 x19.

Root cause

No Marketing Application

Status

Open, Classified

Product code

KCT

Quantity affected

1

Distribution

US distribution to Tennessee.

Date initiated

2025-05-23

Date posted

2025-06-26

Location

Cedar Grove, NJ