Spectra Medical Devices, Llc medical device recall: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98777
- Recall initiated
- Jul 6, 2026
- Classified by FDA
- Aug 11, 2026
- Posted in Enforcement Report
- Aug 19, 2026
- Recalling firm
- Spectra Medical Devices, Llc
- Firm location
- Wilmington, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 6, 2026. FDA classified it 36 days later, on Aug 11, 2026. Distribution reported by FDA: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. Spectra Medical Devices, Llc has 2 recalls in our records.
Recalled products (1)
Z-2873-2026 Class I Ongoing
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.
Codes / lots: 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.
Quantity: TBD
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98777
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.