CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Jewel Precision Reusable Rigid Sterilization Container System recalled
Jewel Precision Sheet Metal & Machining is recalling Jewel Precision Reusable Rigid Sterilization Container System, distributed nationwide in the US. The recall was initiated on 22 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2026-2025
- FDA event ID
- 96957
- Recalling firm
- Jewel Precision Sheet Metal & Machining, Cedar Grove, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 25 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 May 2025 | Recall initiated by company | |
| 25 Jun 2025 | Classified by FDA | +34 days |
| 2 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
Where it was distributed
US Nationwide distribution in the states of IN, NY, PA.
Questions about this recall
Why was it recalled?
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Which lots are affected?
Model No JP-24-6. GTIN: 00850043393016. All lots shipped up to May 23, 2025.
Where was it sold?
US Nationwide distribution in the states of IN, NY, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Jewel Precision Sheet Metal & Machining
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Jewel Precision Reusable Rigid Sterilization Container System recalled | Jewel Precision Sheet Metal & Machining | Sterility | TN |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |