Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium… — Class I medical device recall Z-2873-2026
Ongoing recall by Spectra Medical Devices, Llc, reported 2026-08-19, distributed in CA, FL, NC, OK, TX, VA. Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the prod
| Recall number | Z-2873-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spectra Medical Devices, Llc, Wilmington, MA, United States |
| Recall initiated | 2026-07-06 |
| Classified | 2026-08-11 |
| Reported by FDA | 2026-08-19 |
| Distributed | CA, FL, NC, OK, TX, VA |
| Reason classes | foreign material, sterility |
| Lot numbers | AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005, AB4006, AB5001, AB5002, AB5003, AB5004, AB5005, AB5006, AB5007, AB5008 |
| Model numbers | AMPUL10MLK |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2873-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.