Drug & Device Safety Atlas

FDA recall record · openFDA

Jewel Precision Sheet Metal & Machining Co, Inc.

2 FDA recalls on record (2025) — 2 device. 2 still ongoing.

0
Class I (most serious)
2
Class II
0
Class III
2
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was 1
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. 1

Recalls

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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