Spectra Medical Devices recall: Sodium Chloride Injection
Spectra Medical Devices, Llc is recalling Sodium Chloride Injection because of foreign material – TBD. The U.S. Food and Drug Administration published the recall on August 19, 2026; it began on July 6, 2026. Distributed in 6 states (California, Florida, North Carolina, Oklahoma, Texas, Virginia).
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | Sodium Chloride Injection |
| Brand | Spectra Medical Devices |
| Company | Spectra Medical Devices, Llc |
| Type | Medical devices |
| Classification | Class I |
| Recall date | July 6, 2026 |
| Published by FDA | August 19, 2026 |
| Quantity | TBD |
| Recall ID | 98777 |
Recalled products
- 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.
- FDA recall number
- Z-2873-2026
- Codes, lots and dates
- 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
- Classification
- Class I
Identifiers and details
- FDA event ID
- 98777
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Wilmington, MA, United States
Why it was recalled
The problem: foreign material.
The reason the FDA lists: “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.”
Where it was sold
6 states: California, Florida, North Carolina, Oklahoma, Texas, Virginia. Distribution as the FDA records it: “Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 98777, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Spectra Medical Devices Sodium Chloride Injection recalled?
Yes. Spectra Medical Devices, Llc recalled it on July 6, 2026; FDA published it August 19, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of foreign material. The reason given: 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 should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
In 6 states (California, Florida, North Carolina, Oklahoma, Texas, Virginia).
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.