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U.S. Department of Health and Human Services

Class 2 Device Recall Jewel Precision Reusable Rigid Sterilization Container System

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 Class 2 Device Recall Jewel Precision Reusable Rigid Sterilization Container Systemsee related information
Date Initiated by FirmMay 22, 2025
Date PostedJune 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2026-2025
Recall Event ID 96957
510(K)NumberK162600 
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
ProductJewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Code Information Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Recalling Firm/
Manufacturer		 Jewel Precision Sheet Metal & Machining Co, Inc.
200 Commerce Rd
Cedar Grove NJ 07009-1209
For Additional Information ContactLorenzo Graziano
1-973-8575545 Ext. 15
Manufacturer Reason
for Recall		The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
FDA Determined
Cause 2		No Marketing Application
ActionJewel Precision notified consignees on about 05/22/2025 via email. Consignees were instructed to acknowledge the notification, inform Jewel Precision of their distribution of the products, obtain old Instructions for Use from their customers, return any obsolete Instructions for Use to Jewel Precision, and send updated Instructions for Use to their customers.
Quantity in Commerce11 units
DistributionUS Nationwide distribution in the states of IN, NY, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KCT
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