Z-2026-2025Class II

Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6

Name: Z-2026-2025 Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6
Creator: Jewel Precision Sheet Metal & Machining Co, Inc.
Published: 2025-05-22
License: https://open.fda.gov/license/

Jewel Precision Sheet Metal & Machining, Inc. / initiated 2025-05-22 / Open, Classified / root cause: labeling and UDI

FDA source

Jewel Precision Sheet Metal & Machining Co, Inc. began a recall of Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6 on 2025-05-22. FDA classified it as Class II and gives the reason as "The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2026-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-06-25
Recalling firm: Jewel Precision Sheet Metal & Machining, Inc.
Product: Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: Jewel 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 commerce: 11 units
Distribution: US Nationwide distribution in the states of IN, NY, PA.
Product codes and lots: Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2026-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2026-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-25

Product code KCT

K162600Class IIJewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. / cleared 2016-12-09

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)