Recall Summary
| Recall number | Z-2873-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-08-19 |
| Company | Spectra Medical Devices, Llc |
| Units affected | TBD |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
The spectra medical recall involves a common hospital product. The U.S. Food and Drug Administration issued recall number Z-2873-2026 on August 19, 2026. The recalling company is Spectra Medical Devices, Llc. The product is Sodium Chloride Injection, 0.9%, USP, in 10mL ampules. It is sold under the Elevaris and Spectra Medical Devices brand names. Regulators assigned this action a Class I severity classification. That is the most serious category the FDA uses. This guide explains what was recalled, what the risk is, and what to do next.
What the Spectra Medical Recall Covers
The recalled item is a saline flush solution. Its full name is Sodium Chloride Injection, 0.9%, USP 10mL Ampule. The model and catalog number is AMPUL10MLK. The brand names listed on the agency record are Elevaris and Spectra Medical Devices. The recalling firm is Spectra Medical Devices, Llc.
The product is used as a sodium chloride flush. Clinicians use it on IV tubing systems. They also use it on indwelling intravascular access devices. These include ports, PICC lines, and central venous catheters. A flush clears the line and keeps it open between uses. As a result, this is a routine, high-volume item in clinical settings.
The spectra medical recall points to a contract manufacturing issue. The agency record names the manufacturing firm as Huons. Huons was cited for issues regarding product quality and sterility assurance. In other words, the concern began at the manufacturing site. It is not a design flaw in how a flush works.
The FDA record for this spectra medical recall lists the scope as TBD. That means the number of affected units has not been published in the record we are working from. Distribution dates and geographic reach are likewise not stated. However, that gap is common in early Class I postings. For the current unit count and lot detail, check the official notice linked on this page.
The Hazard and Reported Injuries
The hazard here is sterility. A flush goes directly into the bloodstream. There is no barrier between the solution and the patient. Typically, sterility failures are treated as serious for that reason alone. The FDA agreed and assigned Class I status.
The agency states the potential harm plainly. If product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. That exposure may trigger inflammatory responses. It may also cause infections, micro-clots, and organ failure. These are the risks the agency identified in this spectra medical recall.
It is important to be precise about what is known. The agency record does not state whether injuries have been reported. We will not claim that injuries occurred. We will also not claim that none occurred. Neither statement is supported by the record. For example, a Class I designation describes potential for serious harm. It is not itself a count of injuries.
The table below summarizes the verified agency data for this spectra medical recall.
| Recall number | Z-2873-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | August 19, 2026 |
| Company | Spectra Medical Devices, Llc |
| Product | Sodium Chloride Injection, 0.9%, USP 10mL Ampule (AMPUL10MLK) |
| Manufacturing firm cited | Huons |
| Units affected | Not stated in the agency record (TBD) |
| Severity classification | Class I |
What To Do If You Own This Product
Stop using the product first. Do not flush any line with it. Set the affected stock aside. Mark it clearly so no one grabs it by mistake. In most cases, quarantining inventory is the fastest way to stop further exposure.
Next, identify what you have. Look at the label and the carton. Check for the product name Sodium Chloride Injection, 0.9%, USP 10mL Ampule. Check for the catalog number AMPUL10MLK. Check for the Elevaris or Spectra Medical Devices brand name. Write down any lot numbers and expiration dates you find.
We are not stating the remedy here. The remedy text in the agency record did not match this product, so it has been withheld. Follow the instructions in the official notice linked on this page instead. That notice is the authoritative source for returns, replacement, disposal, and reimbursement. Do not guess at the correct handling step.
Patients should talk to their care team. Ask whether this product was used in your treatment. Ask what symptoms would warrant a call. Fever, chills, redness at an access site, or new pain deserve prompt attention. However, do not stop prescribed treatment on your own. Facilities and distributors should also contact Spectra Medical Devices, Llc directly through the official notice.
Does a Spectra Medical Recall Mean You Can Sue?
A recall is not a lawsuit. That is the plainest way to say it. A recall is a safety action. A regulator or a company removes a product from use to prevent harm. It is a correction, not a finding of legal liability.
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So the spectra medical recall, by itself, is not a legal claim. Owning a recalled product is not an injury. Returning a recalled product is not an injury either. Typically, courts look for something more before a case can move forward.
That something more usually has two parts. First, an actual injury or documented harm. Second, causation, meaning evidence linking the product to that harm. Medical records, treatment dates, and product identification all matter here. For example, records showing which lot was used during a procedure can be important. As a result, documentation is often the difference between a viable claim and no claim.
If you believe you were harmed, speak with a licensed attorney in your state. An attorney can review your records and your timeline. They can explain filing deadlines, which vary by state. You may be eligible to pursue a claim depending on the facts. However, no outcome is guaranteed, and nothing on this page is legal advice.
How Recalls Connect to Mass Tort Cases
Recalls and litigation are separate tracks. However, they often intersect later. A recall notice creates a dated public record. It documents what the company knew and when it acted. It also names the defect or the quality failure. In litigation, that record can become evidence.
History shows the pattern. Philips recalled millions of CPAP and BiPAP devices in 2021 over sound-abatement foam degradation. That recall was followed by consolidated federal litigation and a later settlement program. Takata airbag inflators were recalled across many automakers over rupture risk. That recall also preceded extensive litigation and a bankruptcy-linked compensation process.
Neither example predicts anything about the spectra medical recall. No litigation over this recall has been verified, and we are not suggesting any exists. The point is narrower. A recall can supply facts that later matter, including manufacturing citations like the sterility findings at Huons. In most cases, though, the recall stays exactly what it is: a safety measure.
Frequently Asked Questions
What product is affected by the spectra medical recall?
The affected product is Sodium Chloride Injection, 0.9%, USP 10mL Ampule, catalog number AMPUL10MLK. It is branded Elevaris and Spectra Medical Devices. It is used as a flush for IV tubing and indwelling intravascular access devices.
What does Class I mean in the spectra medical recall?
Class I is the FDA’s most serious recall category. It means there is a reasonable probability that use of the product could cause serious health consequences or death. It reflects potential risk, not a confirmed injury count.
How many units are involved in the spectra medical recall?
The agency record lists the scope as TBD, so the unit count is not published there. Distribution details are also not stated. Check the official FDA notice linked on this page for updated scope information.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed August 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.