Severity
Moderate
FDA Devices recall · Reported July 2, 2025
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Jewel Precision Sheet Metal & Machining Co, Inc. recalled Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-2… - a moderate-severity action.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-2… was recalled by Jewel Precision Sheet Metal & Machining Co, Inc. in July 2, 2025. Reason: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.. Check the official notice for the remedy. Verify recall #Z-2026-2025 with the FDA Devices before acting.
The recall
Jewel Precision Sheet Metal & Machining Co, Inc. issued this moderate-severity FDA Devices recall-The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2026-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2026-2025) was formally reported on July 2, 2025, with the manufacturer initiating the action on May 22, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Jewel Precision Sheet Metal & Machining Co, Inc. is listed as the recalling firm, operating out of Cedar Grove, NJ. Federal records list the affected scope as 11 units.
The documented reason for this recall is: The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of IN, NY, PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
11 units
Related Recalls
6
3 from same agency
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2026-2025 |
| Date reported | July 2, 2025 |
| Date initiated | May 22, 2025 |
| Recalling firm | Jewel Precision Sheet Metal & Machining Co, Inc. |
| Firm location | Cedar Grove, NJ |
| Affected scope | 11 units |
| Distribution | US Nationwide distribution in the states of IN, NY, PA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
· 2026-07-02
· 2026-06-25
· 2026-06-18
GE Medical Systems Information Technologies Inc · 2026-06-03
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 2, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.