FDA Devices recall · Reported August 19, 2026
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.
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganis…
Spectra Medical Devices, Llc recalled Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.… - a critical-severity action.
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.… was recalled by Spectra Medical Devices, Llc in August 19, 2026. Reason: Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the pro…. Check the official notice for the remedy. Verify recall #Z-2873-2026 with the FDA Devices before acting.
The recall
Spectra Medical Devices, Llc issued this critical-severity FDA Devices recall-Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the pro….
- Critical
- severity level
- Class I
- classification
- August 19, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2873-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2873-2026) was formally reported on August 19, 2026, with the manufacturer initiating the action on July 6, 2026. It is classified under Critical severity (Class I), with a current status of Ongoing. Spectra Medical Devices, Llc is listed as the recalling firm, operating out of Wilmington, MA. Federal records list the affected scope as TBD.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.. 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, 6 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.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2873-2026 |
| Date reported | August 19, 2026 |
| Date initiated | July 6, 2026 |
| Recalling firm | Spectra Medical Devices, Llc |
| Firm location | Wilmington, MA |
| Affected scope | TBD |
| Distribution | Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. |
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.
- Check the recall number (Z-2873-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026