CLASS I ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Elevaris Sodium Chloride Injection recalled by Spectra Medical Devices
Spectra Medical Devices is recalling Elevaris Sodium Chloride Injection, 0.9%, USP, distributed in California, Florida, North Carolina, Oklahoma, Texas, Virginia. The recall was initiated on 6 Jul 2026 and the FDA has classified it as Class I.
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-2873-2026
- FDA event ID
- 98777
- Recalling firm
- Spectra Medical Devices, Wilmington, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 6 Jul 2026
- FDA classified
- 11 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 6 Jul 2026 | Recall initiated by company | |
| 11 Aug 2026 | Classified by FDA | +36 days |
| 19 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
Where it was distributed
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
Questions about this recall
Why was it recalled?
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
Which lots are affected?
Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits.
Where was it sold?
Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Spectra Medical Devices
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCl Injection USP, mL, Single-Dose Ampules recalledLidocaine Hydrochloride | Spectra Medical Devices | Sterility | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |