FDA Medical Device Recalls (openFDA)
Jewel Precision Sheet Metal & Machining Co, Inc.: Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
- Recall number
- Z-2026-2025
- Recalling firm
- Jewel Precision Sheet Metal & Machining Co, Inc.
- Product
- Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
- Status
- Open, Classified
- Initiated
- 2025-05-22
- Posted
- 2025-06-25
- Terminated
- not on file
- Reason
- The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
- 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
- 11 units
- Distribution
- US Nationwide distribution in the states of IN, NY, PA.
- Lot, serial or model codes
- Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
- 510(k) numbers
- K162600
- PMA numbers
- not on file
- Product code
- KCT
- Firm FEI
- 3004112448
- Firm city
- Cedar Grove
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28