Z-2033-2025Class II

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

Name: Z-2033-2025 Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8
Creator: Jewel Precision Sheet Metal & Machining Co, Inc.
Published: 2025-05-23
License: https://open.fda.gov/license/

Jewel Precision Sheet Metal & Machining, Inc. / initiated 2025-05-23 / Open, Classified / root cause: sterility

FDA source

Jewel Precision Sheet Metal & Machining Co, Inc. began a recall of Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8 on 2025-05-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2033-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-06-26
Recalling firm: Jewel Precision Sheet Metal & Machining, Inc.
Product: Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.
Root cause tag: sterility
FDA root cause: No Marketing Application
Action: 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: [email protected] or call 973-857-5545 x19.
Quantity in commerce: 1
Distribution: US distribution to Tennessee.
Product codes and lots: Model No JP-24-8. GTIN: 00850043393139. Lot Number: 16899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2033-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2033-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-26

Product code KCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)